MAUDE Adverse Event Report: TORNIER S.A.S. ASC FLEX ECCENT REVERS PLATFORM TRIAL D40 TH 0 EXC 3.5 STD; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	MWF520S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2022
Type of Reportable Event	Malfunction
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 the instrument had a broken plastic at the center.
Additional Manufacturer Narrative
Please note the corrections in the h6 clinical signs code and the health impact code: 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 signs of extensive usage as evident by scratches and worn-out surface.The center portion of device is completely broken off from the device.The surface of broken piece indicates exposure to high mechanical force.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 was attributed to combination of normal wear & a user related issue.However, a scope of improvement was identified to address the issue and a design change is in progress to avoid the recurrence of this issue.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that the that the instrument had a broken plastic at the center.

• Brand Name: ASC FLEX ECCENT REVERS PLATFORM TRIAL D40 TH 0 EXC 3.5 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: 15540843
• Report Number: 3000931034-2022-00339
• Device Sequence Number: 16611799
• Product Code: LXH
• UDI-Device Identifier: 03700386977008
• UDI-Public: 03700386977008
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2023

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: MWF520S
• Device Catalogue Number: MWF520S
• Device Lot Number: 13F258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2014
• 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