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

Catalog Number	OM-1503
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem 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).
Additional 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.
Additional 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
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7315590
• Report Number: 3006524618-2018-00105
• Device Sequence Number: 18859448
• Product Code: MBI
• UDI-Device Identifier: 00817470006216
• UDI-Public: 00817470006216
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081497
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/19/2018

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 02/06/2018
• Supplement Date Received by Manufacturer: 02/06/2018; 10/30/2018
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 04/19/2018; 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1