MAUDE Adverse Event Report: TORNIER INC PERFORM HUMERAL HEAD IMPACTOR TIP

Catalog Number	MWM054
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
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 on the 7th impact it just broke.
Event or Problem Description
It was reported that on the 7th impact it just broke.
Additional Manufacturer Narrative
The reported event could be confirmed, based on the images provided and matches the alleged failure mode.The device inspection was not possible as the product was not returned for investigation.However, based on the provided images, the device shows clear evidence of structural failure.The impactor tip is fractured into two segments at the proximal end where the impactor connects to the handle.The nature of breakage pattern suggests a brittle failure mode.Additionally, blood residues are present on the surface of the impactor.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The capa is in progress to prevent the reoccurrence of the issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: PERFORM HUMERAL HEAD IMPACTOR TIP
• 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: 23638942
• Report Number: 0001649390-2025-00844
• Device Sequence Number: 9917949
• Product Code: HWA
• UDI-Device Identifier: 00846832082964
• UDI-Public: (01)00846832082964(10)CV0122146
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 02/09/2026

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: MWM054
• Device Lot Number: CV0122146
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2022
• 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