MAUDE Adverse Event Report: TORNIER INC AFR T20 DRIVER BIT; BIT, SURGICAL

Catalog Number	ARS1026400
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that the end of the drill bit broke off.
Event or Problem Description
It was reported that the end of the drill bit broke off.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned and matches the alleged failure mode.The device inspection revealed the following: the received device shows a complete fracture of the shaft at the distal end near the tip that completely bisects the diameter of the screwdriver with the torx head driver broken off and missing.The fracture surface is relatively flat and granular in appearance.The observed fracture features are consistent with a brittle torsional failure.Due to the nature of the retuned device a functional or dimensional inspection was not possible since the returned device was returned broken with a functional and measurable part of the instrument broken off and missing.However, during manufacturing, functionality test and dimensional inspection were done according to specifications.During the inspection, all devices met the specifications.Additionally, a material hardness test was performed on the instrument and met manufacturing specifications.Based on investigation, the root cause was attributed to a user related issue.The event was caused by torsional forces being applied to it beyond it design limits, resulting in a brittle fracture.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.If more information is provided, the case will be reassessed.

• Brand Name: AFR T20 DRIVER BIT
• Common Device Name: BIT, SURGICAL
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23524587
• Report Number: 0001649390-2025-00805
• Device Sequence Number: 10074362
• Product Code: GFG
• UDI-Device Identifier: 00846832079193
• UDI-Public: (01)00846832079193(11)200319(21)AZ0119340
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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): 03/30/2026

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: ARS1026400
• Device Lot Number: AZ0119340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2020
• 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