MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED HEX SCREWDRIVER BIT; HEXAGONAL SCREWDRIVER TIP

Catalog Number	MWB991
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.
Event or Problem Description
During the surgical procedure, the surgeon (b)(6) implants the 10 ° tilted sphere, the medical device is correctly positioned on the base plate.When the surgeon was finishing screwing the glenoid sphere to the base plate with the 3.5mm hexagonal screwdriver (reference mwb991, lot 19b815) the tip of the screwdriver broke, leaving the fragment within the hexagon of the glenoid sphere screw.The surgeon tried for 15 minutes to remove the fractured tip of the screwdriver from the glenoid sphere without success.Surgeon (b)(6), observing that this fragment remained fixed and cannot be removed, decides to leave it within the hexagon of the glenoid sphere.The surgery ends without further serious events and the patient does not present serious problems or impacts.
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.This submission does not constitute a determination or admission that a device has malfunction or is related to a death or injury.

• Brand Name: AEQUALIS REVERSED HEX SCREWDRIVER BIT
• Common Device Name: HEXAGONAL SCREWDRIVER TIP
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 11122702
• Report Number: 3000931034-2021-00002
• Device Sequence Number: 700865
• Product Code: HXX
• UDI-Device Identifier: 03700386971006
• UDI-Public: 03700386971006
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2020

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: MWB991
• Device Lot Number: 19B815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR