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

Catalog Number	MWA301
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "screw fell out and inner part was loose in the box".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Please note correction to d9/h3.Following a review on the photo provided, it was observed that the screw is missing and the pusher plate is no longer maintained.The investigation concluded that the root cause was attributed to a user related issue as there was an incorrect assembly of the screw after the cleaning and sterilization process.However, the bone graft occurs away from the patient.Therefore, the chances of the debris and or other parts of the device being left in the patient are negligible and almost impossible.Therefore, this record is deemed non-reportable.
Event or Problem Description
As reported: "screw fell out and inner part was loose in the box".

• 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: 17862262
• Report Number: 3000931034-2023-00324
• Device Sequence Number: 20266287
• Product Code: HXD
• UDI-Device Identifier: 03700386968297
• UDI-Public: 03700386968297
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2023

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 Catalogue Number: MWA301
• Device Lot Number: 19C758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2019
• 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: Unknown