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	Malposition of Device (2616)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	08/13/2025
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 initial surgery took place on (b)(6) 2025, xray image was then taken on (b)(6) 2025, issue was found that the shs migrated medially.Each operation was performed by a different doctor/clinical team; revision surgery performed on (b)(6) 2025.".
Event or Problem Description
As reported: "the initial surgery took place on (b)(6) 2025, xray image was then taken on (b)(6) 2025, issue was found that the shs migrated medially.Each operation was performed by a different doctor/clinical team; revision surgery performed on (b)(6) 2025.".
Additional Manufacturer Narrative
Corrections: please refer to section h6 (results codes).The reported event could be confirmed since the device was not returned for evaluation, but available radiograph confirms the alleged event.With the available radiograph, a formal medical opinion was sought: we see a basicervical fnf here.The positioning of the nail and the lag screw is not optimal, but good.However, these fractures have an increased risk of failure due to the mismatch between the diameter of the cortical bone of the proximal and distal fragments, leading to an inherent instability.This specific fracture pattern provides the lag screw with a pretty high force in the medial direction, which is visible here.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.The operative technique states that: ¿the set screw must be used.Insufficient set screw placement could lead to loss of lag screw fixation and postoperative complications.¿ indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.Based on the available information, the exact root cause could not be determined, but multiple probable causes can be identified, such as the set screw was not tightened appropriately, or the traction forces generated by mobilization acting on the lag screw exceeded the fixation provided by the set screw.Therefore, a mixture of patient-related factors (fracture pattern) and potentially a user-related issue could have been the reason for the failure.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• 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: 23342890
• Report Number: 0008031020-2025-01982
• Device Sequence Number: 12751885
• Product Code: HSB
• UDI-Device Identifier: 07613327478877
• UDI-Public: 07613327478877
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 81251170S
• Device Lot Number: UNKNOWN
• 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: 09/23/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 02/03/2026
• 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