MAUDE Adverse Event Report: STRYKER GMBH T2 - DRILL, AO D3.5X230 MM; BIT, DRILL

Catalog Number	18063540
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
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: "during drilling with t2 surgical instrument drill tip ao type 3.5 diameter, 230m length, the drill tip broke off due to interference with the guide pin.The drill tip was removed from the patient's body and the procedure was completed without any problems.".
Additional Manufacturer Narrative
The reported event could be confirmed, although the device was not returned but the x-rays confirmed the alleged breakage.A device inspection was not possible since the affected device was not returned.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.A few post-op and post failure x-rays were shared for evaluation.These were presented to our hcp whose opinion was that the reduction was not adequate enough.The dislocation/gap between the proximal and distal part is still significant, the fracture parts do not really seem to touch or be close to each other.Therefore, this suggest that reason is non-union since, after a year, we see little callus bridging, which is related to the gap, which was too big.Based on the x-ray evaluation, the breakage of the nail most likely happened due to the non-union, but more information, as well as the affected device, must be available in order to determine the exact root cause of the issue.If the device is returned, or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "during drilling with t2 surgical instrument drill tip ao type 3.5 diameter, 230m length, the drill tip broke off due to interference with the guide pin.The drill tip was removed from the patient's body and the procedure was completed without any problems.".

• Brand Name: T2 - DRILL, AO D3.5X230 MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23137847
• Report Number: 0008031020-2025-01635
• Device Sequence Number: 9831883
• Product Code: HWE
• UDI-Device Identifier: 04546540196606
• UDI-Public: (01)04546540196606(11)190813(10)K092676
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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: 18063540
• Device Lot Number: KU111395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2019
• 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: Male