MAUDE Adverse Event Report: ARTHROCARE CORPORATION 1.8MM Q-FIX SOFT SUTURE ANCHOR; FIXATION ANCHOR, LIGAMENT, NON-BIODEGRAD

Catalog Number 25-1800

Device Problems Device Slipped (1584); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2014

Event Type  malfunction  

Event Description

It was reported that during a shoulder procedure using a 1.8mm q-fix all suture anchor, upon deployment the sutures pulled out of the implant when the metal tubing was retracted.This implant was successfully removed, but it was necessary to drill a new bone hole to complete the procedure.There were no significant delays or pt complications reported as a result of this event.

• Brand Name: 1.8MM Q-FIX SOFT SUTURE ANCHOR
• Type of Device: FIXATION ANCHOR, LIGAMENT, NON-BIODEGRAD
• Manufacturer (Section D): ARTHROCARE CORPORATION; austin TX
• Manufacturer (Section G): ARTHROCARE COSTA RICA; la aurora, heredia ; CS
• Manufacturer Contact: wendy laird ; 7000 w william cannon dr; bldg one; austin, TX 78735 ; 5123585933
• MDR Report Key: 3894338
• MDR Text Key: 4538973
• Report Number: 3006524618-2014-00050
• Device Sequence Number: 1
• Product Code: MBI
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 01/22/2014

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 Expiration Date: 01/31/2014
• Device Catalogue Number: 25-1800
• Device Lot Number: 1045525
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/23/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/22/2014
• Initial Date FDA Received: 02/19/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/16/2013
• 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
• Patient Outcome(s): Other