MAUDE Adverse Event Report: ARTHROCARE CORPORATION MAGNUM 2 KNOTLESS IMPLANT; FIXATION ANCHOR, LIGAMENT, NON-BIODEGRAD

Catalog Number OM-1502

Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913)

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

Event Date 05/05/2015

Event Type  malfunction  

Event Description

It was reported that 4 weeks after a shoulder procedure using a magnum 2 knotless implant, the implant pulled out of the bone.A revision surgery was necessary to retrieve the non functional implant, however no further implants were needed as the ligaments had already healed and reattached to the bone at this point.There were no additional patient complications reported as a result of this event.

Manufacturer Narrative

No device has been returned, customer provided batch number for evaluation purposes.Visual inspection and functional testing could not be performed because the device in question was not returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.A review of the device history records and quality records associated with this was not possible as no lot number was provided.

• Brand Name: MAGNUM 2 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: 4804542
• MDR Text Key: 5829495
• Report Number: 3006524618-2015-00086
• 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: User Facility,user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/05/2015

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 Catalogue Number: OM-1502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2015
• Initial Date FDA Received: 05/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 65 YR