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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
During a surgical procedure involving item dwd194, the driver tip dwd167 broke off inside the head of a locking screw.A new dwd194 was opened and used, with a total of 3 dwd167 tips used to complete the surgery.The surgeon opened a new dwd167 to remove the initial sphere and another to re-implant the replacement sphere.The incident occurred during primary surgery, and there was no excessive force or hard bone encountered.
Additional Manufacturer Narrative
Corrections: h6 clinical signs code, health impact code, d4 lot # and serial #:.The reported event was confirmed, since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the device broke at the hexagonal tip level.A visual microscopic inspection showed that the device rupture corresponded to a ductile fracture caused by a torsional torque (twisted tip), indicating that the device was subjected to high force during use (final central screw tightening step).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.It states that: "it is mandatory that the glenoid sphere is screwed manually", "single use devices cannot be reused", "instruments should be examined for wear or damage prior to surgery".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 overload that contributed to the reported event.If any further information is provided, the complaint report will be updated.
Event or Problem Description
During a surgical procedure involving item dwd194, the driver tip dwd167 broke off inside the head of a locking screw.A new dwd194 was opened and used, with a total of 3 dwd167 tips used to complete the surgery.The surgeon opened a new dwd167 to remove the initial sphere and another to re-implant the replacement sphere.The incident occurred during primary surgery, and there was no excessive force or hard bone encountered.

• 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: 18837371
• Report Number: 3000931034-2024-00077
• Device Sequence Number: 15237052
• Product Code: HTW
• UDI-Device Identifier: 03700386943775
• UDI-Public: 03700386943775
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/22/2024

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?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Male