MAUDE Adverse Event Report: ARTHROCARE CORP. MAGNUM X WITH INDEPENDENT TENSIONIN; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number OM-1503

Device Problems Inadequacy of Device Shape and/or Size (1583); Cut In Material (2454)

Patient Problem No Information (3190)

Event Date 02/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the wire inside the magnum x anchor on the tensioning wheel became exposed after several turns preventing continued tensioning of the suture and the anchor had to be abandoned.A magnum 2 anchor was then tried, but the length of suture available to load into the anchor was less than required so it could not be properly tensioned via the tensioning knobs and that anchor was also abandoned.Complaint 2 of 2.See related (b)(4).

Manufacturer Narrative

The reported magnum x device, intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.Without the reported product a visual evaluation cannot be performed and customers complaint cannot be confirmed.From the information provided, snare wire became exposed after several turns and was unable to continue tensioning.An exact root cause cannot be determined with confidence; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: excessive force.Excessive force applied during tensioning the snare can result in device failure during snaring or suture tensioning.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

Manufacturer Narrative

The device, intended for use in treatment, was returned as an mdr for evaluation.There was a relationship found between the device and the reported incident.Visual inspection of the magnum x, om-1503 shows a deployed device with a detached magnum x implant and with a pressed suture lock button.Both of the snare lines are completely reeled through the driver with broken end loops.No sutures are present.The independent tensioning button is working as specified.There are no manufacturing abnormalities visually observed with the returned device.The magnum x is a single use device and could not be functional tested.A limited functional test was performed: the hand lever and the suture ratchet knobs can be rotate easily and the reels can be turned as intended.The complaint was verified and the root cause could not be determined with certainty.There was no indication that the device did not meet product specifications upon release into distribution.

• Brand Name: MAGNUM X WITH INDEPENDENT TENSIONIN
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7315590
• MDR Text Key: 101987599
• Report Number: 3006524618-2018-00105
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00817470006216
• UDI-Public: 00817470006216
• Combination Product (y/n): N
• PMA/PMN Number: K081497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: OM-1503
• Device Lot Number: 1149193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Date Manufacturer Received: 10/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1