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

Catalog Number	DWD167
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/01/2019
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 my case yesterday with dr.(b)(6) at (b)(6) surgery center, the tip of the one time use hex screwdriver, part #dwd167 broke off inside the glenosphere, part #dwd180 and cold welded together.After trying to utilize a variety of instruments, it was determined that the part was unable to move and had to be left inside of the patient.
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
Event or Problem Description
During my case yesterday with dr.(b)(6) at (b)(6) surgery center, the tip of the one time use hex screwdriver, part #dwd167 broke off inside the glenosphere, part #dwd180 and cold welded together.

• 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: 8619221
• Report Number: 3000931034-2019-00080
• Device Sequence Number: 11272439
• Product Code: HXX
• UDI-Device Identifier: 03700386943775
• UDI-Public: 03700386943775
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2019

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: No Information
• Device Expiration Date: 12/04/2023
• Device Catalogue Number: DWD167
• Device Lot Number: 0493AU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 10/22/2019
• 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