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

Catalog Number MWD148

Device Problem Material Fragmentation (1261)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/12/2019

Event Type  malfunction  

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 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).

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS REVERSED
• Type of Device: GLENOID SPHERE EXTRACTOR SCREW
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• Manufacturer Contact: maud andriollo-sanchez ; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 8320595
• MDR Text Key: 135536219
• Report Number: 3000931034-2019-00026
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 03700386972010
• UDI-Public: 03700386972010
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: MWD148
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/12/2019
• Initial Date FDA Received: 02/08/2019
• Supplement Dates Manufacturer Received: 01/12/2019
• Supplement Dates FDA Received: 10/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other