MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED DISPOSABLE DRIVER TIP; AEQUALIS REVERSED DISPOSBALE DRIVER TIP

Catalog Number	DWD167
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/16/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.(please refer to medwatch report sent by hospital (b)(6) (b)(4).
Event or Problem Description
Patient was in the or undergoing a total shoulder replacement surgery and was under anesthesia.Glenoid sphere implant was secured into place with hex screwdriver bit.When it was removed from the implant, the tip remained within the insertion hole.The patient remained stable (no apparent harm).The surgeon noted he was unable to remove.Post-op x-rays showed no loose hardware and all hardware was secure.The patient recovered well and no harm was apparent.
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.(please refer to medwatch report sent by hospital (b)(4).

• Brand Name: AEQUALIS REVERSED DISPOSABLE DRIVER TIP
• Common Device Name: AEQUALIS REVERSED DISPOSBALE DRIVER TIP
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 7224182
• Report Number: 3000931034-2017-00065
• Device Sequence Number: 3414768
• Product Code: HXX
• UDI-Device Identifier: 03700386943775
• UDI-Public: 03700386943775
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2017

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 Expiration Date: 09/30/2021
• Device Catalogue Number: DWD167
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/07/2017
• Initial Report FDA Received Date: 01/29/2018
• Supplement Report FDA Received Date: 01/29/2018
• 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: 82 YR