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

Catalog Number	MWJ123
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
While explanting a perform 15 degree full wedge baseplate the screwdriver tip broke inside the head of the central screw.After several attempts removing the baseplate was aborted.A new sphere was fully seated, impacted and screwed in tightly.The tip of the screwdriver was not retrieved.It remained in the central screw head.

• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 25512161
• Report Number: 0001649390-2026-00550
• Device Sequence Number: 10552817
• Product Code: HXX
• UDI-Device Identifier: 00846832062461
• UDI-Public: (01)00846832062461(11)250909(10)AZ0425136
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: MWJ123
• Device Lot Number: AZ0425136
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/02/2026
• 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: 05/22/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 06/15/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown