MAUDE Adverse Event Report: TORNIER S.A.S. CANNULATED REAMER DRIVER; BIT, SURGICAL

Catalog Number	MWE151
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Upon inspection found mwe151 broken and needs to be replaced.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Correction: please refer to h6 (device & health impact) codes.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 indicates significant wear and extensive usage.The shaft region of the device has circular gouge and abrasion marks.The distal region of the driver shows clear signs of wear and mechanical stress.The red circled region highlights deformation along the edge, with visible irregularities that suggest repeated force or impact.The surface appears rough and dull, with multiple water spots, indicating frequent exposure to cleaning or sterilization processes.These features are consistent with extensive use and possible material fatigue.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 combination of user-related factors and progressive wear.The deformation and expansion observed at the distal engagement area suggest that excessive torsional force was applied during operation, likely while engaging or disengaging the reamer.Additionally, the dull surface and presence of water spots indicate frequent cleaning and sterilization cycles which may have gradually weakened the material and contributed to its compromised structural integrity.Improper handling during use or reprocessing further accelerated the damage.If any further information is provided the complaint report will be updated.
Event or Problem Description
Upon inspection found mwe151 broken and needs to be replaced.
Additional Manufacturer Narrative
Correction: emdr data - fda registration number (montbonnot), d3 (legal manufacturer), g1 (manufacturing site).
Event or Problem Description
Upon inspection found mwe151 broken and needs to be replaced.

• Brand Name: CANNULATED REAMER DRIVER
• Common Device Name: BIT, SURGICAL
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin MN 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin MN 38330 ; FR 38330
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22904601
• Report Number: 0001649390-2025-00599
• Device Sequence Number: 20833352
• Product Code: GFG
• UDI-Device Identifier: 03700386973871
• UDI-Public: (01)03700386973871(10)20C711
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 03/03/2026

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 Catalogue Number: MWE151
• Device Lot Number: 20C711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 09/30/2025; 02/04/2026
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 10/28/2025; 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2021
• 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