MAUDE Adverse Event Report: TORNIER S.A.S. ASC FLEX ECCENT REVERS PLATFORM TRIAL D40 TH 0 EXC 1.5 STD; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	MWF510S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that broken mwf510s instrument trial this afternoon.The screw placement snapped on extraction of the trial on the revive trial stem.
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.
Event or Problem Description
It was reported that broken mwf510s instrument trial this afternoon.The screw placement snapped on extraction of the trial on the revive trial stem.
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 visual inspection of the returned device reveals scratches and wear marks.The blue central plastic part was found to completely broken off the trial.The nature of the fracture indicates towards a brittle fracture.The threading has completely broken off the device resulting in the attachment screw to break free.Several deep scratches and gouge marks are also observed on the metal surface.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 related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed due to unintended and majorly design related issue.The failure was caused by abnormal usage of the device by user and a design change is in progress to avoid that the issue occurs again.If any further information is provided, the complaint report will be updated.

• Brand Name: ASC FLEX ECCENT REVERS PLATFORM TRIAL D40 TH 0 EXC 1.5 STD
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16799104
• Report Number: 3000931034-2023-00116
• Device Sequence Number: 6417427
• Product Code: LXH
• UDI-Device Identifier: 03700386976940
• UDI-Public: 03700386976940
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 06/16/2023

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 Model Number: MWF510S
• Device Catalogue Number: MWF510S
• Device Lot Number: 19C103
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2019
• 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