MAUDE Adverse Event Report: Tornier Inc PERFORM REVERSED PERIPHERAL and SPHERE SCREWDRIVER BIT T20; Bit, surgical

Catalog Number	MWJ127
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "found tip of driver to be sheared off.".
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.

• Brand Name: PERFORM REVERSED PERIPHERAL and SPHERE SCREWDRIVER BIT T20
• 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 ; +1(201)831-5000
• MDR Report Key: 50046410
• Report Number: 0001649390-2026-00761
• Device Sequence Number: 9617174
• Product Code: GFG
• UDI-Device Identifier: 00846832062492
• UDI-Public: (01)00846832062492(11)250529(10)FH0125118
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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: Other
• Device Catalogue Number: MWJ127
• Device Lot Number: FH0125118
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/24/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 06/29/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• 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