MAUDE Adverse Event Report: TORNIER INC PERFORM REVERSED PERIPHERAL & SPHERE SCREWDRIVER BIT T20; BIT, SURGICAL

Catalog Number MWJ127

Device Problem Fracture (1260)

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

Event Date 09/28/2021

Event Type  malfunction  

Event Description

It was reported that the driver broke during use in a surgery.No patient complications were reported.

Manufacturer Narrative

Device evaluation is anticipated upon return to manufacturer.If additional information becomes available, it will be provided on a supplemental report.

Manufacturer Narrative

The reported event could be confirmed.The device was returned and found to be in the condition stated in the event description.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by user.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 any further information is provided, the complaint report will be updated.

Event Description

It was reported that the driver broke during use in a surgery.No patient complications were reported.

• Brand Name: PERFORM REVERSED PERIPHERAL & SPHERE SCREWDRIVER BIT T20
• 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: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 12701143
• MDR Text Key: 283966426
• Report Number: 3004983210-2021-00071
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 00846832062492
• UDI-Public: 00846832062492
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MWJ127
• Device Lot Number: FH0120138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/03/2020
• 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