MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED HEX SCREWDRIVER BIT; STERILE DRIVER PIN

Catalog Number	DWD167
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is the initial 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.
Event or Problem Description
The tip of the driver broke off in the glenosphere.Tip could not be found & was left in patient.About 5 minutes was added to case.

• Brand Name: AEQUALIS REVERSED HEX SCREWDRIVER BIT
• Common Device Name: STERILE DRIVER PIN
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 11670394
• Report Number: 3009351194-2021-00036
• Device Sequence Number: 3527435
• Product Code: HXX
• UDI-Device Identifier: 03700386943775
• UDI-Public: 03700386943775
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/17/2021

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: Lay User/Patient
• Device Expiration Date: 10/29/2025
• Device Catalogue Number: DWD167
• Device Lot Number: 6014AV
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 04/15/2021
• 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