MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - INTERMEDIATE NAIL, RIGHT D10X240MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	82250240S
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The distributor contacted sr the day after the operation to report that the surgeon had completed the procedure whilst both distal screws remained out of position.Following the operation, sr met with the doctor, but as the surgeon made no mention of this, it cannot be definitively confirmed whether the screws were indeed out of position.Additional information: sr visited the doctor to confirm this matter.The surgeon stated that he had not noticed the incorrect screw position during the operation; it was only discovered on the postoperative x-ray.The screw was not reinserted.This was because the screw hole had become relatively large in relation to the cortical bone, raising concerns about a secondary fracture at that site.Given the patient's wide medullary cavity, this was interpreted as a state of high nail occupancy, and it was decided not to impose any weight-bearing restrictions.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The distributor contacted sr the day after the operation to report that the surgeon had completed the procedure whilst both distal screws remained out of position.Following the operation, sr met with the doctor, but as the surgeon made no mention of this, it cannot be definitively confirmed whether the screws were indeed out of position.Additional information: sr visited the doctor to confirm this matter.The surgeon stated that he had not noticed the incorrect screw position during the operation; it was only discovered on the postoperative x-ray.The screw was not reinserted.This was because the screw hole had become relatively large in relation to the cortical bone, raising concerns about a secondary fracture at that site.Given the patient's wide medullary cavity, this was interpreted as a state of high nail occupancy, and it was decided not to impose any weight-bearing restrictions.

• Brand Name: GAMMA4 - INTERMEDIATE NAIL, RIGHT D10X240MM 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: 23776339
• Report Number: 0008031020-2025-02149
• Device Sequence Number: 18640135
• Product Code: HSB
• UDI-Device Identifier: 07613327593723
• UDI-Public: (01)07613327593723(17)340831(10)K1D48EF
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K230512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 82250240S
• Device Lot Number: K1D48EF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2024
• 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
• Patient Sex: Unknown