MAUDE Adverse Event Report: Stryker GmbH T2 - Nail Handle; Orthopedic Manual Surgical Instrument

Catalog Number	18061006
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that: "a 40-year-old patient was admitted to the hospital following a traffic accident with a left femoral diaphyseal fracture requiring.Description of the incident osteosynthesis using an intramedullary nail, model ref.1825-1140s.During the pre-disinfection of the nail holder after the nail was inserted, the operator noticed that a piece of the nail holder was missing and notified the surgeon.Clinical consequences and current status of the patient : no consequences for the patient; the procedure was able to proceed.Presence of a 3x3x1 mm metal fragment inside of the implanted nail.Very low risk of migration according to the surgeon.Any migration would be limited to the bony structures with no other associated risk.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.

• Brand Name: T2 - Nail Handle
• Common Device Name: Orthopedic Manual Surgical Instrument
• 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: 50543812
• Report Number: 0008031020-2026-01439
• Device Sequence Number: 10650841
• Product Code: LXH
• UDI-Device Identifier: 04546540196552
• UDI-Public: 04546540196552
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 09/01/2026

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: 18061006
• Device Lot Number: KH1033475
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Sex: Unknown