MAUDE Adverse Event Report: Stryker GmbH T2 - TROCAR, SHORT; Orthopedic manual surgical instrument

Catalog Number	18060310
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that, they received the additional shipment.One of the medical devices received was defective upon arrival as it was bent.It cannot be used.They asked for the replacement of this device.
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.

• Brand Name: T2 - TROCAR, SHORT
• 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: 25802652
• Report Number: 0008031020-2026-00845
• Device Sequence Number: 5999798
• Product Code: LXH
• UDI-Device Identifier: 04546540196385
• UDI-Public: (01)04546540196385(10)K1A689D
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 18060310
• Device Lot Number: K1A689D
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/07/2026
• 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: 06/15/2026
• Supplement Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 07/13/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2026
• 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
• Patient Sex: Unknown