MAUDE Adverse Event Report: TORNIER S.A.S. REVERSED II CANNULATED HANDLE FOR REAMER; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	MWD156
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the reaming of the joint fossa was not done properly due to a large shake of the reamer shaft.And whether due to this or simply a bad blade on the 25mm bp reamer, the reaming of the joint fossa was not done properly.This caused difficulty in screw entry and insufficient the base plate placement (contact area) on the joint surface.
Event or Problem Description
It was reported that the reaming of the joint fossa was not done properly due to a large shake of the reamer shaft.And whether due to this or simply a bad blade on the 25mm bp reamer, the reaming of the joint fossa was not done properly.This caused difficulty in screw entry and insufficient the base plate placement (contact area) on the joint surface.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: the returned device has evident scratch marks at the distal as well as proximal part.The teeth are slightly bent and dull in appearance due to excessive use of the device.The pre-surgical functional test of the returned device reveals that the components assembled without any hinderance, and it worked well.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 a user related issue.The failure was caused by prolong usage of device.The failure is caused by definitive wear and tear marks which are a result of prolong usage of device over the time involving repetitive cleaning and sterilization cycles.If any further information is provided, the complaint report will be updated.

• Brand Name: REVERSED II CANNULATED HANDLE FOR REAMER
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 16057876
• Report Number: 3000931034-2022-00391
• Device Sequence Number: 14761795
• Product Code: HWE
• UDI-Device Identifier: 03700386972096
• UDI-Public: 03700386972096
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/06/2023

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: MWD156
• Device Catalogue Number: MWD156
• Device Lot Number: 20D650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2022
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 12/27/2022
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2021
• 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