MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT TRIAL 3/4 42MM DIA +0 45%; TEMPLATE

Catalog Number	MWP2420
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 a component was identified as unusable by spd staff after a pan was dropped off for processing.Upon inspection, the poly was found to be deformed and indented, raising concerns about the sterility of the device.
Event or Problem Description
It was reported that a component was identified as unusable by spd staff after a pan was dropped off for processing.Upon inspection, the poly was found to be deformed and indented, raising concerns about the sterility of the device.
Additional Manufacturer Narrative
The reported event was confirmed, since an image of the instrument were provided and match the alleged failure mode.The device inspection revealed the following: an evaluation of the image provided by the facility shows there are gouges of material missing from the outer rim of the device¿s interior concave profile along with some superficial surface scratches.Since the item was not returned a functional and dimensional inspection were not possible.However, during manufacturing, functionality test and dimensional inspection were done according to specifications.During the inspection, all devices met the specifications.Based on investigation, the root cause was attributed to a wear related issue.The event was caused by repeated use and reprocessing cycles.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: PERFORM REV INSERT TRIAL 3/4 42MM 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22469808
• Report Number: 0001649390-2025-00507
• Device Sequence Number: 11830357
• Product Code: HWT
• UDI-Device Identifier: 00846832083633
• UDI-Public: (01)00846832083633(10)AB00422519
• 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,Followup
• Report Date (Section B): 10/27/2025

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: MWP2420
• Device Lot Number: AB00422519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2022
• 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