MAUDE Adverse Event Report: TORNIER INC PERFORM HUMERAL IMPACTOR TIP SIZE 3/4

Catalog Number	MWM052
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the surgeon broke plastic 3-4 tornier impactor tip.
Additional Manufacturer Narrative
The reported event could be confirmed, as the device was returned and matched the alleged failure mode.Device inspection revealed the following findings.Evaluation of the returned instrument identified a diagonal brittle fracture extending from the top of the impactor tip to approximately the midpoint of the instrument.The upper portion of the instrument was fractured and received as a separate piece.Impact-related deformations were also observed along the base of the instrument.This failure mode is consistent with repetitive high-energy impact loading.A functional inspection could not be performed because the device was clearly broken and rendered non-functional.A dimensional inspection was also not possible, as the device was returned in multiple pieces, altering measurable features.However, during manufacturing, functional testing and dimensional inspections were performed in accordance with specifications, and all devices met requirements at that time.Following the investigation, a nonconformance was initiated, and a design modification is currently underway to prevent recurrence of this issue.Based on the investigation, the root cause was attributed to a device design-related issue.A review of the device history record for the reported lot did not identify any abnormalities.No corrective actions are required at this time.A review of the labeling also did not identify any abnormalities.If additional information becomes available, the case will be reassessed.
Event or Problem Description
It was reported that the surgeon broke plastic 3-4 tornier impactor tip.

• Brand Name: PERFORM HUMERAL IMPACTOR TIP SIZE 3/4
• Common Device Name: IMPACTOR
• 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: 23827026
• Report Number: 0001649390-2025-00950
• Device Sequence Number: 4992738
• Product Code: HWA
• UDI-Device Identifier: 00846832082803
• UDI-Public: 00846832082803
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 04/21/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: MWM052
• Device Lot Number: CV0222343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2022
• 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