MAUDE Adverse Event Report: TORNIER INC PERFORM REVERSED LATERALIZED GLENOSPHERE TRIAL (+3MM) 42MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	MWJ138
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while removing the trial from the baseplate, the central plastic portion that surrounds the screw broke off from the surrounding trial.The issue was noticed as the small piece of plastic was still in the joint, and was noticed by the surgeon.
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Additional Manufacturer Narrative
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 received device shows sign of extensive usage as evident by wear marks on the device surface.Centre of the trail show obvious signs of breakage, it can be established that the breakage is due to cyclic loading, which subsequently resulted in fatigue fracture.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 a user related issue.The failure was caused by cyclic loading which resulted into a fatigue fracture.If any further information is provided, the investigation report will be reassessed.
Event or Problem Description
It was reported that while removing the trial from the baseplate, the central plastic portion that surrounds the screw broke off from the surrounding trial.The issue was noticed as the small piece of plastic was still in the joint, and was noticed by the surgeon.

• Brand Name: PERFORM REVERSED LATERALIZED GLENOSPHERE TRIAL (+3MM) 42MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 15284393
• Report Number: 3004983210-2022-00058
• Device Sequence Number: 7092139
• Product Code: LXH
• UDI-Device Identifier: 00846832062591
• UDI-Public: 00846832062591
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2022

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: MWJ138
• Device Catalogue Number: MWJ138
• Device Lot Number: CR2416300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2022
• Supplement Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2017
• 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