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

Catalog Number	MWM054
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Broken impactor tip.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Broken impactor tip.
Additional Manufacturer Narrative
Correction: please see h6 (device code).The reported event could be confirmed since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the visual inspection of the returned device exhibits rough and extensive usage.The impactor tip is broken into two pieces at the proximal end where the humeral head of impactor connects the handle.The nature of breakage pattern indicates to be a brittle fracture.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.Based on investigation the root cause was attributed to combination of design and normal usage related issue.The failure was caused by its intended use.As a device that is manufactured of plastic and incurs numerous impaction events, cleaning and sterilization cycles breakage as noted in this complaint can be expected.A design improvement is in progress to prevent the recurrence of the alleged failure.If any further information is provided the complaint report will be updated.

• 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: 23028249
• Report Number: 0001649390-2025-00655
• Device Sequence Number: 15907668
• Product Code: HWA
• UDI-Device Identifier: 00846832082964
• UDI-Public: (01)00846832082964(10)CV0122146
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/24/2025

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: MWM054
• Device Lot Number: CV0122146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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