MAUDE Adverse Event Report: TORNIER INC PERFORM HUMERAL IMPACTOR TIP SIZE 3/4

Catalog Number	MWM052
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
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 the impactor tip broke while being unscrewed from the handle following completion of the surgical procedure.Additionally, during post-operative decontamination, it was observed that the glenosphere trial had plastic material broken out from the back around the screw area.
Additional Manufacturer Narrative
Correction: d9 product available to stryker.H6 method, results, conclusion and health codes.The reported event was confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: visual inspection.The visual inspection of the returned device shows evident breakage.The impactor is broken in two pieces.Gauge marks creating material removal space at the proximal end.The device has black marks and spots stuck inside pitch of the threads.The nature of the breakage indicates brittle fracture.Overall damage indicating 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.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 user related issue.Most likely, the failure was caused by improper and rough usage.Furthermore, the issue noted in this event is currently under the scope of a capa to implement a design enhancement.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that the impactor tip broke while being unscrewed from the handle following completion of the surgical procedure.Additionally, during post-operative decontamination, it was observed that the glenosphere trial had plastic material broken out from the back around the screw area.

• Brand Name: PERFORM HUMERAL IMPACTOR TIP SIZE 3/4
• 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: 23538656
• Report Number: 0001649390-2025-00816
• Device Sequence Number: 4769851
• Product Code: HWA
• UDI-Device Identifier: 00846832082803
• UDI-Public: (01)00846832082803(11)210302(10)CV0221311
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 02/02/2026

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: MWM052
• Device Lot Number: CV0221311
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2021
• 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