MAUDE Adverse Event Report: ARTHROCARE CORPORATION MULTIFIX P KNOTLESS FIXATION DEVICE; FIXATION ANCHOR, LIGAMENT, NON-BIODEGRAD

Catalog Number OM-1300

Device Problems Device Operates Differently Than Expected (2913); Torn Material (3024)

Patient Problem No Code Available (3191)

Event Date 01/30/2014

Event Type  malfunction  

Event Description

It was reported via the patient that several months following a shoulder procedure involving a multifix p knotless fixation device, the patient had a re-tear and alleged that the device failed.The patient states that a different surgeon chose to do a revision surgery to implant a different anchor.No further details were provided regarding the specific details or actual cause of failure or the severity.

• Brand Name: MULTIFIX P KNOTLESS FIXATION DEVICE
• 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 1; austin, TX 78735 ; 5123585933
• MDR Report Key: 4669373
• MDR Text Key: 19359821
• Report Number: 3006524618-2015-00056
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K120096
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2015
• Device Catalogue Number: OM-1300
• Device Lot Number: 1028091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2012
• 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
• Patient Age: 49 YR