MAUDE Adverse Event Report: TORNIER SAS AEQUALIS REVERSED HEXAGONAL DRIVER TIP

Catalog Number MWB991

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/28/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Driber tip broke upon screwing in the glenosphere, the fragment remained implanted.

• Brand Name: AEQUALIS REVERSED HEXAGONAL DRIVER TIP
• Type of Device: AEQUALIS REVERSED HEXAGONAL DRIVER TIP
• Manufacturer (Section D): TORNIER SAS; montbonnot, ; FR
• Manufacturer Contact: segolene pollet ; FR
• MDR Report Key: 5185144
• MDR Text Key: 190037823
• Report Number: 3000931034-2015-00100
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/28/2015

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: MWB991
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2015
• Initial Date FDA Received: 10/28/2015
• 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