MAUDE Adverse Event Report: ARTHROCARE CORP. MAGNUM 2 KNOTLESS IMPLANT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	OM-1502
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an open rotator cuff repair procedure, after loading the magnum implant into the device, the surgeon removed the suture slack outside of the joint using the ratchet, pushed the device into the pilot hole, then removed further slack whilst the anchor was inserted into the pilot hole.At this point, the wire mechanism snapped and the ratchet system of the magnum would not work.The snare wire then poked out of the device near the ratchet knob.The surgeon removed the device and freed both suture ends from the device.The procedure was successfully completed without significant delay using a suture from a metal twinfix ultra anchor which was inserted into the patient as the medial row anchor and the suture limbs of which were then loaded into the magnum 2 anchor in the same bone hole.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
It was reported that during a open rotator cuff repair procedure, after loading the magnum implants into the device, the surgeon removed the suture slack outside of the joint using the ratchet, pushed the device into the pilot hole, then removed further slack whilst the anchor was inserted into the pilot hole.At which point, the wire mechanism snapped and the ratchet system of the magnum would not work.The snare wire then poked out of the device near the ratchet knob.Same issue happened with the second device used.The surgeon removed the device and freed both suture ends from the device and tried again with a different magnum 2 implant using the same pilot hole.The procedure was successfully completed without significant delay using a suture from a metal twinfix ultra anchor which was inserted into the patient as the medial row anchor and the suture limbs of which were then loaded into the magnum 2 anchors in the same bone hole.No other complications were reported.

• Brand Name: MAGNUM 2 KNOTLESS IMPLANT
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10727357
• Report Number: 3006524618-2020-00915
• Device Sequence Number: 16922080
• Product Code: MBI
• UDI-Device Identifier: 00817470005486
• UDI-Public: 00817470005486
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K042914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/20/2022
• Device Model Number: OM-1502
• Device Catalogue Number: OM-1502
• Device Lot Number: 2035865
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention