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

Catalog Number	MWM052
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
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 3/4 stem impactor broke during the case.
Additional Manufacturer Narrative
Correction: h6 device code.The reported event could be confirmed, since the product was returned for evaluation.The device inspection revealed the following: the visual inspection of the returned device reveals that the impact tip has fractured into two separate pieces.Several external impact marks are evident on the tip¿s surface.The observed breakage pattern, originating from the specimen¿s edge and characterized from the v-shaped feature, suggests catastrophic failure brittle in nature likely due to rough handling or excessive application of mechanical force.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing related problems were found during the investigation.Based on investigation, the root case was attributed to design and intended use related issues.The failure was caused by intended use.As a device that is manufactured of radel plastic and incurs numerous impaction events, cleaning and sterilization cycles, breakage as noted in this complaint can be expected.A design change is already identified to prevent the recurrence of the alleged failure.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that the 3/4 stem impactor broke during the case.

• 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: 22787249
• Report Number: 0001649390-2025-00554
• Device Sequence Number: 8144934
• Product Code: HWA
• UDI-Device Identifier: 00846832082803
• UDI-Public: (01)00846832082803(10)CV0222343
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

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: MWM052
• Device Lot Number: CV0222343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 12/03/2025
• 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