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

Catalog Number	MWM054
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the peg broke off of the trial and the impactor tip broke in half.
Additional Manufacturer Narrative
Should additional information become available, it will be provided on a supplemental report.
Additional Manufacturer Narrative
Reportability update: investigation results have concluded that the device showed signs of a crack instead of breakage.This event is no longer reportable.Should any changes occur, a supplemental report will be provided.Corrections: b5 executive summary: d9 returned to manufacturer on.The reported event was confirmed since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following.The received device shows signs of extensive usage as evident by wear marks and deformed edges.The impactor tip is cracked near the end where the impactor handle connects with the tip.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.Based on investigation the root cause was attributed to a combination of user and design related issues.There are multiple reasons causing this failure first by improper usage and second can be its intended use.As a device that is manufactured of 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 any further information is provided the complaint report will be updated.
Event or Problem Description
It was reported that during a primary surgery, the peg cracked on the cortiloc trial and the impactor tip broke in half.

• 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: 21610769
• Report Number: 0001649390-2025-00159
• Device Sequence Number: 7756379
• Product Code: HWA
• UDI-Device Identifier: 00846832082964
• UDI-Public: (01)00846832082964(11)230209(10)CV0123039
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 05/27/2025

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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