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

Catalog Number	ARS1026400
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the revive torque driver and t20 assembly driver broke during implant construction.No additional information was available.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: visual inspection: a visual inspection found the device to be broken at the tip.There is a clear indication of overtorque present which is consistent with the application of excessive mechanical load and force.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.Based on investigation, the root cause was attributed to a user related issue.There is a clear indication of overtorque present which is consistent with the application of excessive mechanical load and force; therefore, the root cause was attributed to a user related issue.If any additional information is provided, the investigation 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14761115
• Report Number: 0001649390-2022-00025
• Device Sequence Number: 19993512
• Product Code: GFG
• UDI-Device Identifier: 00846832079193
• UDI-Public: 00846832079193
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 06/21/2022

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
• Date Returned to Manufacturer: 06/07/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 06/21/2022
• 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: Male