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

Catalog Number	ARS1026400
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Torque limiting driver would not engage screw.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed based on the device inspection.The device inspection revealed the following: the driver tip shows clear signs of wear and rounding: the edges appear smoothed and slightly rounded, with loss of the original sharp geometry.In addition, several marks and scratches can be observed all over the surface of the device.Overall, these observations are consistent with mechanical wear due to repeated and intensive usage over several years.Then, the returned driver was tested with a sample screw.The driver had difficulties to engage with the screw.Finally, a dimensional inspection was performed.The measured tip diameter was found to be below the specified dimensions.This is most likely due to the above-mentioned usage-related wear, which caused progressive material loss, evident from the smoothed and rounded edges.Even minor dimensional reductions at the driver tip can impair proper engagement.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 investigation, the root cause was attributed to a combination of wear and user-related factors.The event resulted from extensive usage overtime, ultimately leading to progressive material loss and therefore impaired engagement with the screw.If more information is provided, the case will be reassessed.
Event or Problem Description
Torque limiting driver would not engage screw.

• 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: 23413140
• Report Number: 0001649390-2025-00774
• Device Sequence Number: 18413164
• Product Code: GFG
• UDI-Device Identifier: 00846832079193
• UDI-Public: (01)00846832079193(11)240808(10)AZ4023339
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 01/29/2026

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: AZ4023339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2024
• 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