MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED; SCREWDRIVER

Model Number	MWB991
Medical Device Problem Codes	Material Fragmentation (1261); Material Deformation (2976)
Health Effect - Clinical Codes	Failure of Implant (1924); Patient Problem/Medical Problem (2688)
Date of Event	06/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.
Event or Problem Description
During the surgery when the surgeon requested the glenoid sphere for implantation, reference(b)(6), serial number (b)(4), the medical device had the screw blocked, preventing its proper implementation to the base plate.The surgeon tried several times to release the screw until the 3.5 mm hexagonal screwdriver tip broke.The doctor tried to implant other sphere (b)(6), serial number (b)(4) with a new 3.5 mm hexagonal screwdriver but had the same problem and the 3.5 mm hexagonal screwdriver tip broke again.
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS REVERSED
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 6749744
• Report Number: 3000931034-2017-00139
• Device Sequence Number: 16454685
• 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
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2017

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: Physician
• Device Model Number: MWB991
• Device Catalogue Number: 3.5 MM HEXAGONAL TIP DRIVER
• Device Lot Number: 16B351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/01/2017
• Supplement Date Received by Manufacturer: 07/01/2017
• Initial Report FDA Received Date: 07/28/2017
• Supplement Report FDA Received Date: 01/30/2018
• 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