MAUDE Adverse Event Report: Stryker GmbH Gamma4 - Intermediate Nail, LEFT D10x240mm x 130deg; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	83300240S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a gamma nail broke and was revised.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.

• Brand Name: Gamma4 - Intermediate Nail, LEFT D10x240mm x 130deg
• 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: 50158802
• Report Number: 0008031020-2026-01014
• Device Sequence Number: 16096149
• Product Code: HSB
• UDI-Device Identifier: 07613327593921
• UDI-Public: 07613327593921
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

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: 83300240S
• Device Lot Number: K151C50
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 08/06/2026
• 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 Age: 87 YR
• Patient Sex: Female