MAUDE Adverse Event Report: Stryker GmbH T2 ALPHA TIBIA - ADAPTER TIBIA / FEMUR RETROGRADE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23534109
Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
Prior to surgery, an inspection of the instruments revealed a brownish liquid or solid-like substance coming from the knob of the adaptor.Based on the physician's decision that re-cleaning and sterilisation were needed, the surgery was delayed by 30 minutes.There were no substance after re-cleaning and sterilisation, the procedure was completed with the adaptor.It is suspected that the lubricant spray hardened over time, forming a glossy residue.

• Brand Name: T2 ALPHA TIBIA - ADAPTER TIBIA / FEMUR RETROGRADE
• 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: 25338944
• Report Number: 0008031020-2026-00759
• Device Sequence Number: 10128651
• Product Code: HSB
• UDI-Device Identifier: 07613327358056
• UDI-Public: 07613327358056
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2026

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: 23534109
• Device Lot Number: UNKNOWN
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Supplement Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 08/31/2026
• 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
• Patient Sex: Unknown