MAUDE Adverse Event Report: Stryker GmbH GAMMA3 - LONG NAIL KIT R1.5, TI, RIGHT D10X320MM X 120DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	34200320S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	05/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "on (b)(6) 2025, the device was implanted to right femur of the patient.Revision surgery will be performed on (b)(6) 2026 due to nonunion.".

• Brand Name: GAMMA3 - LONG NAIL KIT R1.5, TI, RIGHT D10X320MM X 120DEG
• 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: 25339499
• Report Number: 0008031020-2026-00760
• Device Sequence Number: 17463022
• Product Code: HSB
• UDI-Device Identifier: 04546540375209
• UDI-Public: (01)04546540375209(11)220504(17)270430(10)K0820B4
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2026

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: 34200320S
• Device Lot Number: K0820B4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Supplement Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2022
• 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