MAUDE Adverse Event Report: TORNIER SAS AEQUALIS REVERSED II DRIVER TIP; NONE

Catalog Number MWB991

Device Problems Break (1069); Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/05/2014

Event Type  malfunction  

Event Description

Tip of hex driver broke off and at stuck in glenosphere screw.

Manufacturer Narrative

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

• Brand Name: AEQUALIS REVERSED II DRIVER TIP
• Type of Device: NONE
• Manufacturer (Section D): TORNIER SAS; montbonnot ; FR
• Manufacturer Contact: mireille lemery ; 161 rue lavoisier; monbonnot cedex 38334 ; FR 38334 ; 76613500
• MDR Report Key: 3957308
• MDR Text Key: 17295132
• Report Number: 9610667-2014-00010
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MWB991
• Device Lot Number: 10D326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2014
• Was Device Evaluated by Manufacturer?: No
• 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