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

Model Number	MWM052
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the impactor tip broke during surgery.It is unknown if any debris was left behind in the patient.
Event or Problem Description
It was reported that the impactor tip broke during surgery.It is unknown if any debris was left behind in the patient.
Additional Manufacturer Narrative
The reported event could be confirmed, since the perform humeral impactor tip size ¾ was returned and found to be broken as stated in the complaint event description.The device inspection revealed the following: the impactor tip shows signs of usage.Several black marks and gouges are visible on the returned device.Brittle fracture damage is evident as noted by minimal plastic deformation and visible confirmation that both pieces can be put back together in perfect alignment.Based on the investigation, the root cause was attributed to wear due to intended use.The failure was caused by intended use.As a device that is manufactured of radel plastic and incurs numerous impaction events, cleaning and sterilization cycles, breakage as noted in this complaint can be expected.No corrective actions are required at this time.However, this event has been escalated to a nc within our quality system for further investigation.A review of the labeling did not indicate any abnormalities.A review of the device history for the reported lot did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the complaint report will be updated.

• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15873328
• Report Number: 0001649390-2022-00105
• Device Sequence Number: 19456024
• Product Code: HWA
• UDI-Device Identifier: 00846832082803
• UDI-Public: 00846832082803
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/12/2023

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 Model Number: MWM052
• Device Catalogue Number: MWM052
• Device Lot Number: CV0220363
• 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: 11/02/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2021
• 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