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

Catalog Number ARS1026400

Device Problems Break (1069); Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 295324829
• Report Number: 0001649390-2022-00025
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 00846832079193
• UDI-Public: 00846832079193
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male