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

Catalog Number	MWM052
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A representative reported that the humeral size 3/4 impactor tip broke at the end of a surgical case, but it had no impact on the patient or the surgery time.An update provided additional details: the lot number was not visible on the broken piece after washing, there was no debris that could have fallen into the patient, the issue occurred during a primary surgery, the item was in service for approximately 1 year, it was not part of a loaner kit but a consignment.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Additional Manufacturer Narrative
Please note the correction statement regarding the d9/h3: the reported event was not confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
A representative reported that the humeral size 3/4 impactor tip broke at the end of a surgical case, but it had no impact on the patient or the surgery time.An update provided additional details: the lot number was not visible on the broken piece after washing, there was no debris that could have fallen into the patient, the issue occurred during a primary surgery, the item was in service for approximately 1 year, it was not part of a loaner kit but a consignment.

• 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: 17611383
• Report Number: 0001649390-2023-00213
• Device Sequence Number: 6370111
• Product Code: HWA
• UDI-Device Identifier: 00846832082803
• UDI-Public: 00846832082803
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 10/16/2023

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 Catalogue Number: MWM052
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown