MAUDE Adverse Event Report: Stryker GmbH Gamma3 - Long Nail Kit R1.5, Ti, RIGHT D10x380mm x 130deg; Rod, Fixation, Intramedullary And Accessories

Catalog Number	34300380S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	07/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "during a surgical procedure to remove a femur fracture, it was identified that the aforementioned item broke.".
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.

• Brand Name: Gamma3 - Long Nail Kit R1.5, Ti, RIGHT D10x380mm 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: 50121654
• Report Number: 0008031020-2026-00942
• Device Sequence Number: 10264693
• Product Code: HSB
• UDI-Device Identifier: 04546540375490
• UDI-Public: 04546540375490
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Distributor
• Type of Report: Initial
• Report Date (Section B): 08/03/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 34300380S
• Device Lot Number: K08E8015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 08/03/2026
• 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