MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS FRACTURE NM BONE GRAFT CUTTING DEVICE; CLAMP

Catalog Number	MWA301
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned; therefore, an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
During surgery, the pliers in question were damaged in the plastic part.
Additional Manufacturer Narrative
Correction - please refer h6 clinical code.The reported event could not be confirmed since the device was returned for evaluation.The visual inspection shows that the plastic part of the device was found to be broken into three pieces one broken part remains assembly with the clamp.The breakage pattern indicates a brittle fracture resulted from an application of excessive mechanical force.Moreover, the device indicates presence of water marks and heavy discoloration confirming that the device has gone multiple reprocessing cycles of cleaning & sterilization.Based on investigation, the root cause was attributed to a user related issue.The event was caused by an 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.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
Event or Problem Description
During surgery, the pliers in question were damaged in the plastic part.

• Brand Name: AEQUALIS FRACTURE NM BONE GRAFT CUTTING DEVICE
• Common Device Name: CLAMP
• 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: 20450124
• Report Number: 3000931034-2024-00618
• Device Sequence Number: 15215096
• Product Code: HXD
• UDI-Device Identifier: 03700386968297
• UDI-Public: (01)03700386968297(10)19A454
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2025

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: MWA301
• Device Lot Number: 19A454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2019
• 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: Male