MAUDE Adverse Event Report: ARTHROCARE CORPORATION MAGNUM2 KNOTLESS IMPLANT; FIXATION ANCHOR, LIGAMENT, NON-BIODEGRAD

Catalog Number OM-1502

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Failure to Anastomose (1028)

Event Date 04/08/2014

Event Type  malfunction  

Event Description

It was reported that during a shoulder procedure using a magnum2 knotless implant with a smartstitch perfectpasser suture cartridge, it was discovered that the sutures had become loose after the implant was deployed.The surgeon opted to cut the sutures on this implant and double stack a new like implant on top of the initial magnum2 implant, to complete the procedure.There were no significant delays or patient complications reported as a result of this event.

• Brand Name: MAGNUM2 KNOTLESS IMPLANT
• 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: 3902525
• MDR Text Key: 4426720
• Report Number: 3006524618-2014-00143
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042914
• 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: 04/08/2014

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: 07/01/2016
• Device Catalogue Number: OM-1502
• Device Lot Number: 1046129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/08/2014
• Initial Date FDA Received: 05/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2013
• 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
• Treatment: OM-8176EA, LOT #1047099; SMARTSTITCH PERFECTPASSER SUTURE CARTRIDGE:
• Patient Outcome(s): Other
• Patient Age: 42 YR