MAUDE Adverse Event Report: Stryker GmbH Gamma4 - Long Nail, RIGHT D12x300mm x 125deg; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	84252300S
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	09/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "during the insertion of the u-blade via impaction, the lag screw perforated the femoral head.The lag screw was removed, the void was filled with artificial bone, and the lag screw was reinserted.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.

• Brand Name: Gamma4 - Long Nail, RIGHT D12x300mm 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: 50841188
• Report Number: 0008031020-2026-01613
• Device Sequence Number: 18708020
• Product Code: HSB
• UDI-Device Identifier: 07613327476354
• UDI-Public: 07613327476354
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: Health Professional
• Device Catalogue Number: 84252300S
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/21/2026
• 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: Female