MAUDE Adverse Event Report: Stryker GmbH Gamma4 - RC Lag Screw D10.5x90mm; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81660090S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	06/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, the primary surgery was performed on (b)(6)2025.The revision surgery was performed due to a cutout in the u-lug screw and damage to the u-blade.It was further confirmed that the u blade was broken.No further information was provided.
Additional Manufacturer Narrative
This report was impacted by emdr scheduled maintenance occurring july 22-27, 2026.Additional information has been requested and if received, will be provided in the supplemental report.

• Brand Name: Gamma4 - RC Lag Screw D10.5x90mm
• 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: 50061376
• Report Number: 0008031020-2026-00913
• Device Sequence Number: 9349845
• Product Code: HSB
• UDI-Device Identifier: 07613327591804
• UDI-Public: 07613327591804
• 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
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2026

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: 81660090S
• Device Lot Number: K1DEDD8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 06/26/2026
• Supplement Date Received by Manufacturer: 06/26/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 07/29/2026
• 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: 88 YR
• Patient Sex: Male