MAUDE Adverse Event Report: Stryker GmbH T2 - LOCKING SCREW, FULLY THREADED D5X55 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18965055S
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that, the patient underwent surgery on (b)(6) 2026, for a complex fracture of the proximal femur, treated with a long gamma4 nail.He remained non-weight-bearing for six weeks.A follow-up x-ray performed at that time confirmed that the reduction was stable and that healing had begun.Weight-bearing was then permitted.However, just one month after resuming weight-bearing, the patient experienced a fracture of the osteosynthesis hardware.Upon review of the provided x-rays, deformation of one locking screw was identified.He will undergo reoperation on (b)(6) 2026 for a complex revision procedure involving the removal of the fractured nail, followed by a new osteosynthesis using a long dcs plate combined with a bone graft.

• Brand Name: T2 - LOCKING SCREW, FULLY THREADED D5X55 MM
• 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: 25658433
• Report Number: 0008031020-2026-00789
• Device Sequence Number: 9344288
• Product Code: HSB
• UDI-Device Identifier: 04546540202529
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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: 18965055S
• Device Lot Number: K14F5B6
• 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): Initial
• Initial Date Received by Manufacturer: 06/01/2026
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 06/29/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2025
• 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