MAUDE Adverse Event Report: Stryker GmbH GAMMA4 - INTERMEDIATE NAIL, LEFT D10X240MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	83250240S
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that, postoperatively, the distal screw came loose.A revision surgery was performed to replace the nail with a long nail.No further information was provided.
Additional Manufacturer Narrative
The reported event was confirmed during the investigation.The device inspection revealed the following the identification of the returned nail was confirmed based on the catalog and lot numbers marked on the device.Both the oblong hole and the distal locking hole show signs of significant wear and deformation.It could be concluded that the damage observed in the oblong hole is the result of loosening of the locking screw.Intensive and continuous loading most likely caused displacement of the screw.The subsequent friction between the screw and the hole resulted in the damage observed on both devices.The damage observed in the most distal hole is likely attributable to misdrilling and is also most likely related to screw insertion and subsequent explantation.The returned advanced locking screw was tested with the distal locking hole of the returned nail.The screw was successfully inserted and tightened into the hole, the assembly remained stable.Therefore, any loosening of this screw was ruled out.It was confirmed that the reported loosening occurred between the oblong hole and the locking screw.The advanced locking screw is therefore considered concomitant.The root cause of the screw displacement could not be determined.More information such as patient medical records, patient post-operative activities as well as x-ray images would have been required for a complete investigation.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 more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that, postoperatively, the distal screw came loose.A revision surgery was performed to replace the nail with a long nail.No further information was provided.

• Brand Name: GAMMA4 - INTERMEDIATE NAIL, LEFT 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 GmbH; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 25724687
• Report Number: 0008031020-2026-00814
• Device Sequence Number: 9760102
• Product Code: HSB
• UDI-Device Identifier: 07613327593877
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: 83250240S
• Device Lot Number: K109C6D
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/30/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2026
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 07/06/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2025
• 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: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male