MAUDE Adverse Event Report: STRYKER GMBH T2 TIBIA - TIBIAL NAIL, STANDARD D10X345 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18221034S
Medical Device Problem Codes	Fracture (1260); Device Damaged by Another Device (2915); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a nail holding screw jammed into the nail holding adapter during a t2 tibia nail insertion.This was during a case when the nail would not de-thread from the jig, this resulted in the nail snapping proximally inside the patient, this was removed and replaced with another nail using another set.No reported adverse effects other than a significant time delay.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.

• Brand Name: T2 TIBIA - TIBIAL NAIL, STANDARD D10X345 MM
• 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: 24409267
• Report Number: 0008031020-2026-00183
• Device Sequence Number: 18198704
• Product Code: HSB
• UDI-Device Identifier: 04546540197917
• UDI-Public: (01)04546540197917(17)291031(10)K1E658E
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K003018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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: 18221034S
• Device Lot Number: K1E658E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 02/21/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• 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