MAUDE Adverse Event Report: STRYKER GMBH T2 - UNIVERSAL ROD D9 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060110
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "the universal rod and the t-pin can no longer be connected.".
Event or Problem Description
As reported: "the universal rod and the t-pin can no longer be connected.".
Additional Manufacturer Narrative
The reported event could not be confirmed during the reported event.The device has been released in april 2002, more than 23 years before the reported incident and there is no similar complaint registered for the same lot.This gives solid evidence that the device has been manufactured according to specification.Therefore, no product history review was deemed necessary.The identification of the returned universal rod could be confirmed based on the catalog and the lot number marked.The device exhibits multiple signs of wear.This level of wear is expected, given the device is 23 years old.Overall, the device is in excellent condition.The returned strike plate and universal rod were tested.The devices could be easily assembled, without any issue being observed.Therefore, it could be confirmed that despite the light wear observed, both devices are fully functional.A review of the labeling did not indicate any abnormalities.If more information is provided, the case will be reassessed.

• Brand Name: T2 - UNIVERSAL ROD D9 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23550396
• Report Number: 0008031020-2025-02070
• Device Sequence Number: 9719116
• Product Code: LXH
• UDI-Device Identifier: 04546540196019
• UDI-Public: 04546540196019
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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: 18060110
• Device Lot Number: K883941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2002
• 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