MAUDE Adverse Event Report: STRYKER GMBH TROCHANTERIC NAIL 170MM GAMMA4 Ø10X170MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81250170S
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Intraoperatively, when the u blade was tapped, the lag screw entered deeply into the pelvic direction.The sales rep instructed the surgeon to remove the lag screw and retry the procedure again.Finally, the surgery was finished.It was found that this was caused by an attempt to insert the u-blade with the lag screwdriver handle horizontal to the target device.As a result, the set screw was also not properly fixed, resulting in the lag screw being pushed inward.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
Additional Manufacturer Narrative
Correction - please refer to h6 health impact code.The reported event could not be confirmed due to the lack of evidence.Nonetheless, based on the information received, it could be determined that the root cause is user related, as hcp failed to properly follow the instructions of rc lag screw/u-blade insertion.Indeed, it has been communicated that it was found that this was caused by an attempt to insert the u-blade with the lag screwdriver handle horizontal to the target device.This is a clear deviation of the operative technique.As a reminder, the operative technique instructs that the lag screwdriver handle must be perpendicular (90°) to the targeting arm for a proper rc lag screw insertion and that the lag screwdriver must be removed from the setup prior to the u-blade insertion.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Intraoperatively, when the u blade was tapped, the lag screw entered deeply into the pelvic direction.The sales rep instructed the surgeon to remove the lag screw and retry the procedure again.Finally, the surgery was finished.It was found that this was caused by an attempt to insert the u-blade with the lag screwdriver handle horizontal to the target device.As a result, the set screw was also not properly fixed, resulting in the lag screw being pushed inward.

• Brand Name: TROCHANTERIC NAIL 170MM GAMMA4 Ø10X170MM X 125°
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20887337
• Report Number: 0009610622-2024-00947
• Device Sequence Number: 12723503
• Product Code: HSB
• UDI-Device Identifier: 07613327479058
• UDI-Public: 07613327479058
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 81250170S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2024
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown