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	08/27/2025
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 handle mwm038 was attached to the afflicted instrument mwm052 and implanting dwx3ps into the patient.The impactor tip mwm052 broke into two pieces, one remaining on the handle and the other in the collar of the stem.The prosthesis was removed from the patient, and the broken impactor was taken out of the implant.
Additional Manufacturer Narrative
The reported event was confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: visual inspection of the returned device shows that the impactor tip has fractured into two separate pieces, with chipping evident at the break point.Additionally, black spots and deep scratches are present on the device, indicating signs of rough handling by the user.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 related problems were found during the investigation.Based on investigation, the root cause was attributed to design and intended use related issue.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 handle mwm038 was attached to the afflicted instrument mwm052 and implanting dwx3ps into the patient.The impactor tip mwm052 broke into two pieces, one remaining on the handle and the other in the collar of the stem.The prosthesis was removed from the patient, and the broken impactor was taken out of the implant.

• 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: 23133120
• Report Number: 0001649390-2025-00673
• Device Sequence Number: 9831736
• Product Code: HWA
• UDI-Device Identifier: 00846832082803
• UDI-Public: 00846832082803
• 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): 01/13/2026

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: CV0322144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 66 YR
• Patient Sex: Unknown