MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSE GLENOID BASPLT INSRTR SCREWDRVR T20; SCREWDRIVER

Catalog Number	MWJ123
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Screwdriver broke removing a center screw from a revision.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.

• Brand Name: TORNIER PERFORM REVERSE GLENOID BASPLT INSRTR SCREWDRVR T20
• Common Device Name: SCREWDRIVER
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22547535
• Report Number: 0001649390-2025-00528
• Device Sequence Number: 20586535
• Product Code: HXX
• UDI-Device Identifier: 00846832062461
• UDI-Public: 00846832062461
• 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): 07/18/2025

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: MWJ123
• Device Lot Number: AZ6621236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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