MAUDE Adverse Event Report: TORNIER S.A.S. M40 PEGGED GLENOID TRIAL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	MWE313
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that there was a breakage during the case and a back up was used.
Additional Manufacturer Narrative
The reported event was confirmed since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following the device received shows significant signs of extensive usage evident by the appearance of scratches and gouges.Grasping area is deformed and has grasper marks.Central peg has breakage got separated from the device and is not returned for inspection.The breakage pattern indicates it to be a brittle fracture indicating application of excessive 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 a combination of user and wear related issue.The failure was due to frequent usage and application of excessive mechanical force.If any further information is provided the complaint report will be updated.
Event or Problem Description
It was reported that there was a breakage during the case and a back up was used.

• Brand Name: M40 PEGGED GLENOID TRIAL
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22784872
• Report Number: 3000931034-2025-00445
• Device Sequence Number: 10045745
• Product Code: LXH
• UDI-Device Identifier: 03700386974328
• UDI-Public: 03700386974328
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 11/24/2025

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: MWE313
• Device Lot Number: 12D272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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