MAUDE Adverse Event Report: TORNIER INC PERFORM HUMERAL HEAD IMPACTOR TIP; BIT, SURGICAL

Catalog Number	MWM054
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
The glenosphere was broken after it was struck.It was reported that: "the defect was only noticed after the procedure.".
Additional Manufacturer Narrative
Corrected fields: reporting contact (g1), clinical signs code grid (h6), and health impact code grid (h6).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 reveals breakage.The impactor tip is broken into two pieces at the proximal end where the impactor tip connects the impactor handle.The surface of the device shows multiple visible scratches.The tip also appears to have been used roughly, as evidenced by visible damage marks.The breakage pattern indicates brittle nature of fracture and rough usage.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 combination of design and normal usage related issue.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.
Event or Problem Description
The glenosphere was broken after it was struck.It was reported that: "the defect was only noticed after the procedure.".

• Brand Name: PERFORM HUMERAL HEAD IMPACTOR TIP
• Common Device Name: BIT, SURGICAL
• 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: 21328207
• Report Number: 0001649390-2025-00079
• Device Sequence Number: 20865124
• Product Code: GFG
• UDI-Device Identifier: 00846832082964
• UDI-Public: (01)00846832082964(11)230131(10)CV0222336
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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: CV0222
• 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: 01/10/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2023
• 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