MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT TRIAL 3/4 39MM DIA +0 55%; TEMPLATE

Catalog Number	MWP4390
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Material Disintegration (1177); Fracture (1260); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed, any additional information will be reported in a supplemental report.
Event or Problem Description
Poly got chipped on the bottom and now will not fit in the trial stem.
Event or Problem Description
Poly got chipped on the bottom and now will not fit in the trial stem.
Additional Manufacturer Narrative
Correction: please refer to h6 device code.The reported event could be confirmed, since the device was returned and matches the alleged failure mode.The device inspection revealed the following: a visual inspection of the returned device revealed damage to one edge of the notch on the posterior side of the trial which interfaces with and locks into the compactor during trialing.A portion of material at this location is sheared off and missing.Aside from this localized damage, the remainder of the posterior surface and overall trial exhibit minimal wear and remain in near-new condition.Due to the nature of the returned device a functional inspection was not deemed necessary as a functional portion of the instrument is visibly damaged rendering it non-functional.Based on the investigation, the root cause was attributed to user-related factors.The damaged was consistent with mishandling of the instrument, either through misalignment during use or the application of excessive force during trialing.This conclusion is supported by the overall near-new condition of the instrument, aside from localized shearing damage at a critical interaction point on the posterior aspect of the trail.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 more information is provided, the case will be reassessed.

• Brand Name: PERFORM REV INSERT TRIAL 3/4 39MM DIA +0 55%
• 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: 22547540
• Report Number: 0001649390-2025-00529
• Device Sequence Number: 7014151
• Product Code: HWT
• UDI-Device Identifier: 00846832083435
• UDI-Public: (01)00846832083435(11)230109(10)AB00548249
• 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): 11/25/2025

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: MWP4390
• Device Lot Number: AB00548249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2023
• 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