MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - TROCHANTERIC NAIL 170MM D11X170MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81251170S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "the set screw came loose from the gamma 4 nail.The doctor doesn't know when it came loose.".
Additional Manufacturer Narrative
The reported event could be confirmed during the investigation.A post-operative x-ray image was received.It could be confirmed that the set screw has loosened and migrated form its original position.The most probable root cause to the incident is user related: most probably the set screw was not sufficiently tightened until it was in the lag screw groove.Another explanation could be that the set screw was untightened by more than the advised 1/4 of a turn after having been fully tightened.Therefore, hcp most likely failed to follow the steps described in the operative technique when inserting the set screw.As a reminder, the operative technique clearly states that: turn the set screw driver clockwise.You may notice resistance during insertion due to the self-retaining feature of the set screw thread.Keep turning until you feel contact in one of the grooves of the lag screw.To verify the correct position of the set screw, try to turn the lag screw driver.It is not possible to turn the lag screw driver if the set screw is engaged with the lag screw groove.After tightening the set screw, unscrew the set screw by no more than a quarter (1/4) of a turn, until a small amount of rotation can be felt at the lag screwdriver.This ensures controlled subsidence of the proximal fragment while still preventing medial migration of the lag screw.Warning: do not unscrew the set screw more than ¼ of a turn.Insufficient contact between lag screw and set screw could lead to loss of fixation and post-operative complications".A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the set screw came loose from the gamma 4 nail.The doctor doesn't know when it came loose.".

• Brand Name: GAMMA4 - TROCHANTERIC NAIL 170MM D11X170MM X 125DEG
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23922051
• Report Number: 0008031020-2025-02308
• Device Sequence Number: 18465476
• Product Code: HSB
• UDI-Device Identifier: 07613327478877
• UDI-Public: (01)07613327478877(11)250123(17)341231(10)K0FF4DE
• 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): 01/29/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 81251170S
• Device Lot Number: K0FF4DE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2025
• 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: Other
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Race: Asian