MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT TRIAL 3/4 36MM DIA +0 45%; TEMPLATE

Catalog Number	MWP2360
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that the bottom of poly was damaged and wouldn't seat.

• Brand Name: PERFORM REV INSERT TRIAL 3/4 36MM DIA +0 45%
• Common Device Name: TEMPLATE
• 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: 22445000
• Report Number: 0001649390-2025-00486
• Device Sequence Number: 12816499
• Product Code: HWT
• UDI-Device Identifier: 00846832083640
• UDI-Public: 00846832083640
• 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): 07/08/2025

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: MWP2360
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 07/08/2025
• 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