MAUDE Adverse Event Report: ARTHROCARE CORPORATION 2.8MM Q-FIX SOFT SUTURE ANCHOR; FIXATION ANCHOR, LIGAMENT, NON-BIODEGRAD

Catalog Number 25-2800

Device Problems Material Perforation (2205); Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2014

Event Type  malfunction  

Event Description

It was reported that during a shoulder procedure using a 2.8mm q-fix soft suture anchor, upon tensioning one of the two sutures was cut through.The implant was left intact and a competitive implant was used to reinforce the side where the suture was cut o the initial anchor.There were no significant delays or pt complications reported as a result of this event.

• Brand Name: 2.8MM 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: 3894322
• MDR Text Key: 18547208
• Report Number: 3006524618-2014-00041
• 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: 01/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2014
• 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: 25-2800
• Device Lot Number: 1045527
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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