MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED DISPOSABLE DRIVER TIP

Catalog Number DWD167

Device Problems Break (1069); Difficult to Remove (1528); Material Distortion (2977)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/08/2015

Event Type  Injury  

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

When tightening central screw of glenosphere the tip broke off.Tip remained logged in glenosphere, unable to remove.Tip was left in glenosphere (implanted).

Manufacturer Narrative

(b)(4) device history record was reviewed.Device was made to specification.(b)(4) device must be used only in single use.Breakage may be related to over-tightening of the device during use.This is the final report submitted regarding this surgical event and medical device.

Event Description

When tightening central screw of glenosphere the tip broke off.Tip remained logged in glenosphere, unable to remove.Tip was left in glenosphere (implanted).

• Brand Name: AEQUALIS REVERSED DISPOSABLE DRIVER TIP
• Type of Device: AEQUALIS REVERSED DISPOSABLE DRIVER TIP
• 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 ; 56523528
• MDR Report Key: 5134047
• MDR Text Key: 27804244
• Report Number: 3000931034-2015-00171
• Device Sequence Number: 1
• Product Code: HSB
• 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: Other
• Type of Report: Followup
• Report Date: 09/08/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: DWD167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other