MAUDE Adverse Event Report: STRYKER GMBH T2 ANKLE - ANKLE ARTHRODESIS NAIL, LEFT D10X200MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18181020S
Medical Device Problem Codes	Positioning Failure (1158); Malposition of Device (2616)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "during surgery to insert a t2 ankle nail, a 4.2 mm drill bit broke at both the proximal and distal fixation screw insertion sites after coming into contact with the nail.This resulted in the breakage of two drill bits.As the hospital had a gmma4 fixation drill of the same diameter in stock, this was used as a substitute to complete the operation.".
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.

• Brand Name: T2 ANKLE - ANKLE ARTHRODESIS NAIL, LEFT D10X200MM
• 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 ; 2018315000
• MDR Report Key: 24807298
• Report Number: 0008031020-2026-00538
• Device Sequence Number: 18526038
• Product Code: HSB
• UDI-Device Identifier: 04546540673282
• UDI-Public: (01)04546540673282(17)290331(10)K1B2D32
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051590
• 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): 06/17/2026

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: 18181020S
• Device Lot Number: K1B2D32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2024
• 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 Sex: Unknown