MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - LONG NAIL, LEFT D10X360MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	85250360S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	02/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the patient had a long gamma 4 nail implanted following a left intertrochantetic hip fracture in (b)(6) of 2025.The patient later reported experiencing increased pain.A follow up x-ray seemed to indicate a fractured nail.The device was subsequently revised, and a restoration modular total hip prosthesis was implanted.It was also reported that there was s a potential non-union.
Event or Problem Description
It was reported that the patient had a long gamma 4 nail implanted following a left intertrochantetic hip fracture in (b)(6) 2025.The patient later reported experiencing increased pain.A follow up x-ray seemed to indicate a fractured nail.The device was subsequently revised, and a restoration modular total hip prosthesis was implanted.It was also reported that there was s a potential non-union.
Additional Manufacturer Narrative
The reported event could be confirmed although the device was not returned but an x-ray was shared which confirms the alleged issue.A device inspection was not possible since the affected device was not returned.However, an x-ray was shared which reveals the breakage of the nail from the proximal hole at the level of the lag screw.Along with that both the locking screws at the distal end were also found to be broken.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required currently.No indications of material, manufacturing or design-related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.As indicated in the event description and apparent on the x-ray, the likely reason for failure of nail appears to be non-union, however, more patient data and the affected device must be available to determine the exact root cause of the issue.If the device is received or if any additional information is provided, the investigation will be reassessed.

• Brand Name: GAMMA4 - LONG NAIL, LEFT D10X360MM 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 GMBH; 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: 24698842
• Report Number: 0008031020-2026-00485
• Device Sequence Number: 10151848
• Product Code: HSB
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2026

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: 85250360S
• Device Lot Number: K1CFF7E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2024
• 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