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

Catalog Number	MWM054
Medical Device Problem Codes	Break (1069); Crack (1135); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that during a primary surgery, the impactor tip broke or cracked in half while impacting the sphere implant using the sphere impactor tip.No debris was reported, as the device broke into two pieces, which were removed from the field.The surgery was successfully completed using a different impactor tip.The reporter stated that they tapped the screwdriver to engage screw of sphere and that also helped/worked.The complaint device was not available for evaluation by the manufacturer, as it was reported to be lost.It was approximated that the device has been in service for 2-3 years, and has been used and reprocessed over 100 times.The device was inspected prior to being sent to the customer.
Additional Manufacturer Narrative
Correction to d4(gtin), d9(product available to stryker), g1(reporting contact) ,h3 (device evaluated by mfg), and h6(method 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: a visual inspection of the returned device reveals a brittle fracture that runs across the entire diameter of the instrument, splitting in into two separate pieces.Since there is clear damage to the instrument a functional inspection was not deemed necessary nor possible as it clearly non-functioning.Due to there being clear visible damage to the instrument, a dimensional inspection was not considered necessary nor possible and has damaged measurable features.However, during manufacturing, functionality test and dimensional inspection were done according to specifications.During the inspection, all devices met the specifications.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.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.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 impactor tip broke or cracked in half while impacting the sphere implant using the sphere impactor tip.No debris was reported, as the device broke into two pieces, which were removed from the field.The surgery was successfully completed using a different impactor tip.The reporter stated that they tapped the screwdriver to engage screw of sphere and that also helped/worked.The complaint device was not available for evaluation by the manufacturer, as it was reported to be lost.It was approximated that the device has been in service for 2-3 years, and has been used and reprocessed over 100 times.The device was inspected prior to being sent to the customer.

• 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: 21247654
• Report Number: 0001649390-2025-00049
• Device Sequence Number: 3664693
• Product Code: HWA
• UDI-Device Identifier: 00846832082964
• UDI-Public: (01)00846832082964(10)CV0122146
• 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): 05/01/2025

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: CV0122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/02/2025
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 05/01/2025
• 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 Age: 65 YR
• Patient Sex: Unknown