ARTHREX, INC. DX FIBERTAK SUTURE ANCHOR, ST & NDLS; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
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Model Number DX FIBERTAK SUTURE ANCHOR, ST & NDLS |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/17/2020 |
Event Type
Injury
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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 during a procedure, when a needle from a dx fibertak was found not attached to the suture.The product was already implanted into the patient and could not be removed and a free needle was opened to complete the procedure.Additional information 12/28/2020: it was reported that during a deltoid ligament repair procedure, when a needle from a dx fibertak was suture was not loaded onto the needle when the silicone cover came off.The product was already implanted into the patient and could not be removed.The case was completed with free needle being used for the suture limb.
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Search Alerts/Recalls
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