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	03/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
It was reported that impactor tip was broken during med.Procedure.
Additional Manufacturer Narrative
Corrected field: product available to stryker (d9).The reported event could be confirmed based on the provided device image.The visual inspection of the provided image reveals the impactor tip is broken into two pieces.The breakage pattern indicates it to be a brittle fracture due to an application of excessive 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 or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the exact root cause of the complaint event.However the probable root cause was attributed to a combination of user and design related issues.There are multiple reasons causing this failure a device that is manufactured plastic and incurs numerous impactions resulting into breakage as noted in this complaint can be expected.A design improvement is in progress to prevent the recurrence of the alleged failure if device is returned or any further information is provided the investigation report will be reassessed.
Event or Problem Description
It was reported that impactor tip was broken during med.Procedure.
Additional Manufacturer Narrative
H6(conclusion code).
Event or Problem Description
It was reported that impactor tip was broken during med.Procedure.

• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21726603
• Report Number: 0001649390-2025-00186
• Device Sequence Number: 3808539
• Product Code: HWA
• UDI-Device Identifier: 00846832082964
• UDI-Public: (01)00846832082964(11)230302(21)CV0123032
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2025

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: CV0123032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 05/15/2025; 07/10/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 06/11/2025; 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2023
• 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