MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED HEX SCREW DRIVER BIT D3.5MM L25MM; BIT, DRILL

Catalog Number	DWD167
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the hex screwdriver bit tip broke inside patient when inserting the implant.The surgeon was incapable of removing the broken piece of screw driver bit from the implant.
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Additional Manufacturer Narrative
Correction: b5 h6 component code the reported event could be confirmed, since the device was returned for evaluation and evidences were provided.The device inspection revealed the following: -the screwdriver bit broke at the hexagonal tip.The broken tip of the device was left inside the implant, remained implanted in the patient.-a visual microscopic inspection showed that the device rupture corresponded to a fracture caused by a torsional overload (twisted tip), indicating that the device was subjected to high force during use.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.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by application of a high torsional force that contributed to the reported event.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that the hex screwdriver bit tip broke inside patient when inserting the implant.The surgeon was incapable of removing the broken piece of screw driver bit from the implant.This resulted in a 10-15 min surgical delay.

• Brand Name: AEQUALIS REVERSED HEX SCREW DRIVER BIT D3.5MM L25MM
• Common Device Name: BIT, DRILL
• 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: 17549230
• Report Number: 3000931034-2023-00252
• Device Sequence Number: 15167128
• Product Code: HTW
• UDI-Device Identifier: 03700386943775
• UDI-Public: 03700386943775
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 10/27/2023

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: DWD167
• Device Lot Number: 0371AY
• 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: 07/20/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male