ARTHREX, INC. IMPLANT SYSTEM, FIBERTAK BUTTON; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
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Model Number IMPLANT SYSTEM, FIBERTAK BUTTON |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/05/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
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Event Description
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It was reported that while the surgeon was using the ar-3680 for a proximal inlay biceps tenodesis procedure, the suture knot after deployment failed.After anchor was deployed and set, one suture limb was passed through the anchor and when the second limb was to be shuttled through the anchor, the anchor failed and came out of the tunnel.The fragment was removed and the case was completed by using another ar-3680 without further issue.
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