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

Catalog Number	MWE151
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that during surgery, the tines on the reamer handle broke without being noticed.No replacement was used at the time.After the surgery, while reassembling the trays, it was discovered that the tines were broken.The surgical team and surgeon then called for an x-ray, located the broken piece, and removed it from the patient.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.Indications of material manufacturing or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided the investigation report will be reassessed.
Event or Problem Description
It was reported that during surgery, the tines on the reamer handle broke without being noticed.No replacement was used at the time.After the surgery, while reassembling the trays, it was discovered that the tines were broken.The surgical team and surgeon then called for an x-ray, located the broken piece, and removed it from the patient.

• Brand Name: CANNULATED REAMER DRIVER
• Common Device Name: BIT, SURGICAL
• 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: 20034908
• Report Number: 3000931034-2024-00462
• Device Sequence Number: 3075154
• Product Code: GFG
• UDI-Device Identifier: 03700386973871
• UDI-Public: 03700386973871
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 11/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: MWE151
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown