PFD report

Reginald Victor Smith · Prevention of Future Deaths report

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Issued 21 Jan 2025•Dorset

Report record

Published report and response evidence

This page connects the concerns raised in this report with statements found in recipients’ published responses. A link shows a clear evidence connection; it does not assign responsibility.

View original report
Concerns
3

Raised in this report

Recipients
2

Named on the report

Responses found
2

Of 2 recipients

Stated actions
2

Described in responses

Source document

Full report text

This is the full text from the original published report.

Open published report

Concerns and recipient responses

Select any concern, action or position to view the source wording.

Report evidence summary

Concerns raised3

  1. Lack of auditing and spot checks of surgical jig integrity
    Part of recurring concern: Failure of care and safety auditing to identify deficiencies
  2. Potential deformation of repeatedly used surgical jigs
  3. Lack of preoperative examination of surgical jigs
Responses linked to these concerns

Each statement is shown once, even when linked to more than one concern.

Actions described in response An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.1

  1. Action

    Complete review and publish generic guidance on checking jig condition and preparation, and following implant operative-technique documentation.

    Stated by British Orthopaedic AssociationStated in progressThe respondent said that this action was in progress when they made their response on 21 January 2025.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.3

  1. Position

    Existing safeguards provide sufficient risk mitigation, so no additional actions are proposed at this time.

    Stated by Stryker UK, Ireland, and Northern EuropeExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Lack of auditing and spot checks of surgical jig integrity

Wider context from the report

“2) I have concerns with regard to the following: i) Each jig is used many times in surgery having been sterilised after each procedure. It is hammered into the thigh bone and on this occasion may have become deformed over time. ii) The jig was sent away to the manufacturer for analysis but was lost and so no information was available to the court in relation to its integrity. iii) There is no quality control in place in relation to the examination of the jigs being used (other than when it is assembled in theatre by a nurse) prior to surgery. There is no auditing/ spot checks in relation to the integrity of the jigs. ”

Is this part of a recurring concern?

Yes — Failure of care and safety auditing to identify deficiencies.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Potential deformation of repeatedly used surgical jigs

Wider context from the report

“2) I have concerns with regard to the following: i) Each jig is used many times in surgery having been sterilised after each procedure. It is hammered into the thigh bone and on this occasion may have become deformed over time. ii) The jig was sent away to the manufacturer for analysis but was lost and so no information was available to the court in relation to its integrity. iii) There is no quality control in place in relation to the examination of the jigs being used (other than when it is assembled in theatre by a nurse) prior to surgery. There is no auditing/ spot checks in relation to the integrity of the jigs. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Lack of preoperative examination of surgical jigs

Wider context from the report

“2) I have concerns with regard to the following: i) Each jig is used many times in surgery having been sterilised after each procedure. It is hammered into the thigh bone and on this occasion may have become deformed over time. ii) The jig was sent away to the manufacturer for analysis but was lost and so no information was available to the court in relation to its integrity. iii) There is no quality control in place in relation to the examination of the jigs being used (other than when it is assembled in theatre by a nurse) prior to surgery. There is no auditing/ spot checks in relation to the integrity of the jigs. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

Open source report

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Complete review and publish generic guidance on checking jig condition and preparation, and following implant operative-technique documentation.

Verbatim wording from the response

“The BOA has drafted generic advice for trauma and orthopaedic surgeons on the need for vigilance as to the condition and preparation of any jig used, as well as adherence to the operative technique documentation accompanying each implant.”

Source location

Response from British Orthopaedic Association
Page 2 · response
Published 21 January 2025

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Existing safeguards provide sufficient risk mitigation, so no additional actions are proposed at this time.

Verbatim wording from the response

“Stryker acknowledges the concerns raised but does not propose any additional actions at this time. The safeguards in place, as outlined above, provide sufficient risk mitigation. Furthermore, the reported incident rate remains an extremely rare occurrence, with only 12 similar adverse events reported globally since 2013, despite over 2.6 million lag screws being distributed and implanted successfully in that same timeframe.”

Source location

Response from Stryker (UK) Ltd
Page 3 · response
Published 21 January 2025

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

The targeting system is not designed to be hammered, and proper maintenance preserves its shape and serviceable lifespan.

Verbatim wording from the response

“The Targeting System is specifically designed and intended for repeated use. Its major components are comprised of carbon fiber composite material, ensuring high strength, durability, resistance to deformation and long-term structural integrity. When the instrument is cleaned, sterilized and maintained according to the Instructions for Cleaning, Sterilization, Inspection and Maintenance (“Maintenance Instructions”), it remains undamaged and retains its shape, and its serviceable lifespan is not affected.”

Source location

Response from Stryker (UK) Ltd
Page 1 · response
Published 21 January 2025

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

The hospital and healthcare professionals using the device are responsible for maintenance, handling, inspection, sterilization, storage and pre-use checks.

Verbatim wording from the response

“All instrumentation, including the relevant Targeting Device, is placed with the hospital under a Consignment Agreement. This Agreement explicitly assigns responsibility for appropriate maintenance, handling, inspection, sterilization and storage of the instrumentation to the hospital. This includes pre-use inspections by the operating surgical team.”

Source location

Response from Stryker (UK) Ltd
Page 2 · response
Published 21 January 2025

Open published response

Other statements in published responses

These actions and other statements could not be clearly connected to one concern in this report.

Recipient-stated actions An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.1

  1. 1

    Draft and publish guidance on the number and orientation of intraoperative imaging and postoperative check X-rays.

    Stated by British Orthopaedic AssociationStated plannedThe respondent said that this action was planned when they made their response on 21 January 2025.

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Draft and publish guidance on the number and orientation of intraoperative imaging and postoperative check X-rays.

Verbatim wording from the response

“The BOA will also draft guidance as to the number and orientation of intraoperative imaging and post-operative ‘check’ X-rays.”

Source location

Response from British Orthopaedic Association
Page 2 · response
Published 21 January 2025

Open published response
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Information checked against the published report and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Official responses located
2/2

Data last updated 7 September 2026