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	03/10/2021
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 surgery the tip of the screwdriver broke off in the patient's glenosphere.The tip was firmly edged in the glenosphere and the tip was flush.The tip was left inside the patient as it couldn't be removed despite several attempts using different methods by the surgeon (frazier sucker, dental pick, drilling and burring).As a precaution the surgeon placed bone wax in the hole in the glenosphere over the broken tip to prevent the piece moving if it came loose later.The surgeon has requested advice from the manufacturer as to whether there is any way to remove the broken screwdriver tip if the patient requires a future revision.
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: 11633045
• Report Number: 3000931034-2021-00031
• Device Sequence Number: 3683537
• Product Code: HXX
• UDI-Device Identifier: 03700386971006
• UDI-Public: 03700386971006
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: MWB991
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 07/01/2021
• 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