MAUDE Adverse Event Report: TORNIER INC PERFORM STEMLESS INSERTER HANDLE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number MWM035

Device Problems Break (1069); Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2023

Event Type  malfunction  

Event Description

It was reported that the broach handle broke from hammering implant.No impact to the patient.

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.

Manufacturer Narrative

Correction: d9/h3, h6 method, results, conclusion the reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: visual inspection: a visual inspection of the device shows that the foot and main body are in good condition and that hammer pad 1 and hammer pad 2 have a normal amount of impact deformations from use.Functional inspection: a functional inspection of the device showed that it was functioning normally.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 cannot be established as the device is fully functional and conforms to specification.If any further information is provided, the complaint report will be updated.

Event Description

It was reported that the broach handle broke from hammering implant.No impact to the patient.

• Brand Name: PERFORM STEMLESS INSERTER HANDLE
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 18116159
• MDR Text Key: 328043434
• Report Number: 0001649390-2023-00309
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 00846832082988
• UDI-Public: 00846832082988
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MWM035
• Device Lot Number: AZ7720266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1