MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED; GLENOID SPHERE EXTRACTOR SCREW

Catalog Number	MWD148
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	01/12/2019
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.
Event or Problem Description
The three following instruments are cross threaded and cannot be continued to use.The tip of the glenoid sphere extractor screw (mwd148) broke off inside the wound and it took 1.5 hours to retrieve it.The glenoid sphere extractor screw (mwd148) also became cross threaded in the glenoid sphere extractor 42 mm (mwb218).
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS REVERSED
• Common Device Name: GLENOID SPHERE EXTRACTOR SCREW
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 8320595
• Report Number: 3000931034-2019-00026
• Device Sequence Number: 13875882
• Product Code: HWB
• UDI-Device Identifier: 03700386972010
• UDI-Public: 03700386972010
• 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: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2019

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 Catalogue Number: MWD148
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/12/2019
• Supplement Date Received by Manufacturer: 01/12/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 10/04/2019
• 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