MAUDE Adverse Event Report: ARTHROCARE CORPORATION Q FIX ALL SUTURE ANCHOR; SUTURE UNITS

Catalog Number 25-2800

Device Problem Cut In Material (2454)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/16/2015

Event Type  malfunction  

Event Description

It was reported that during a shoulder procedure, using a 2.8mm q fix all suture anchor, after the anchor was inserted it was noticed that the sutures had been cut.This anchor was left in the bone, and a new bone hole was drilled to complete the procedure using a backup anchor.There were no significant delays or patient complications reported as a result of this event.

• Brand Name: Q FIX ALL SUTURE ANCHOR
• Type of Device: SUTURE UNITS
• Manufacturer (Section D): ARTHROCARE CORPORATION; austin TX
• Manufacturer Contact: wendy laird ; 7000 w william cannon dr; austin, TX 78735 ; 5123585933
• MDR Report Key: 4992230
• MDR Text Key: 24288690
• Report Number: 3006524618-2015-00134
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Not Applicable
• Report Date: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 25-2800
• Device Lot Number: 1101534
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/03/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1