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

Catalog Number OM-1502

Device Problem Shelf Life Exceeded (1567)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/19/2014

Event Type  Other  

Event Description

It was reported that following a shoulder procedure using a magnum2 knotless implant, the implant was discovered to be expired after the procedure was completed.The implant was left in the patient and there have been no 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: 3777892
• MDR Text Key: 4378290
• Report Number: 3006524618-2014-00118
• Device Sequence Number: 1
• Product Code: HTY
• 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: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2014
• Device Catalogue Number: OM-1502
• Device Lot Number: 2113266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2011
• 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