ARTHROCARE CORP. MAGNUM 2 KNOTLESS IMPLANT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number OM-1502 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Information (3190)
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Event Date 10/01/2020 |
Event Type
malfunction
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Event Description
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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.
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Manufacturer Narrative
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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.
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