MAUDE Adverse Event Report: STRYKER GMBH T2 ALPHA TIBIA - TIBIAL NAIL D12X300MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23411230S
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "after inserting the nail, the surgeon attempted to remove the guidewire, but it failed.The procedure was stopped and the nail and guidewire were removed for confirmation.When we checked whether the wire could be passed through the nail outside the patient's body, the guide wire got stuck inside the nail and could not be passed through.The nail was replaced with one size shorter and the procedure continued." this resulted in a 30 minute surgical delay.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "after inserting the nail, the surgeon attempted to remove the guidewire, but it failed.The procedure was stopped and the nail and guidewire were removed for confirmation.When we checked whether the wire could be passed through the nail outside the patient's body, the guide wire got stuck inside the nail and could not be passed through.The nail was replaced with one size shorter and the procedure continued." this resulted in a 30 minute surgical delay.
Additional Manufacturer Narrative
Please note the correction to d4 lot #.The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The received device was visually inspected and found to be in good condition overall without any physical damage.A functional inspection was conducted with a sample guidewire, and it was passed through the nail without any problem.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on the investigation, the root cause can be attributed to user related as the device was observed to be functional in nature in inspection.If more information is provided, the case will be reassessed.

• Brand Name: T2 ALPHA TIBIA - TIBIAL NAIL D12X300MM
• 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 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: 23532385
• Report Number: 0008031020-2025-02061
• Device Sequence Number: 21374166
• Product Code: HSB
• UDI-Device Identifier: 07613327291056
• UDI-Public: (01)07613327291056(11)241126(17)341031(10)K0F49C8
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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: 23411230S
• Device Lot Number: K0F49C8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2024
• 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
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 50 KG