MAUDE Adverse Event Report: TORNIER, INC. TORNIER PERFORM; BIT, SURGICAL

Model Number	MWJ127
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure a piece of the screw bit broke off in the patient's left shoulder.Md pulled out the broken piece.X ray came to the room with a c arm to get x ray.Md confirmed that no pieces were left in the patient's arm utilizing x ray.

• Brand Name: TORNIER PERFORM
• Common Device Name: BIT, SURGICAL
• Manufacturer (Section D): TORNIER, INC.; 10801 nesbitt avenue south; bloomington MN 55437
• MDR Report Key: 25014472
• Report Number: 25014472
• Device Sequence Number: 21408165
• Product Code: GFG
• UDI-Device Identifier: 00846832062492
• UDI-Public: (01)00846832062492
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/13/2026
• Report Date (Section F): 04/13/2026

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
• Device Model Number: MWJ127
• Device Catalogue Number: MWJ127
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 99 KG
• Date Report Sent to FDA: 04/13/2026