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

Catalog Number	MWJ127
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Screwdriver bits were warped or broken.
Additional Manufacturer Narrative
Correction: h6 (device and health impact) codes, d4 (lot number).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 of the returned device showed pronounced deformation at the drive end.The torx drive flutes were twisted, and the driver-end circumference exhibited bending and distortion.These damage features are indicative of repeated exposure to excessive torsional loading, potentially combined with non-axial forces and misalignment during screw engagement.Additionally, material hardness testing was done and the devices was within speciation.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 the investigation, the failure is attributed to user related error.The twisting of the torx drive flutes and bending of the driver-end circumference are consistent with exposure to excessive torsional and/or bending loads, potentially combined with off-axis loading during use.The deformation most likely resulted from mechanical overloading encountered during service.If more information is provided, the case will be reassessed.

• 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: 25764165
• Report Number: 0001649390-2026-00711
• Device Sequence Number: 9898824
• Product Code: GFG
• UDI-Device Identifier: 00846832062492
• UDI-Public: (01)00846832062492(11)240621
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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: MWJ127
• Device Lot Number: FH0124171
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/10/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2026
• Supplement Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 07/09/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2024
• 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