Model Number N/A |
Device Problem
Device Slipped (1584)
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Patient Problem
Failure of Implant (1924)
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Event Date 02/04/2015 |
Event Type
Injury
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Event Description
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It was reported that during a right wrist ligament repair utilizing suture anchors on (b)(6), 2015.During the procedure, four anchors were attempted for use unsuccessfully as they pulled out of the patient's bone.Additional suture anchors and competitor product were used to complete the procedure.
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.This report is number 2 of 4 mdrs filed for the same event (reference 1825034-2015- 00749 / 00752).
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch and to report device evaluation results.Product was returned for evaluation on (b)(4) 2015.Examination of returned device found no evidence of product non-conformance.Product likely failed due to misuse, by not properly positioning/aligning with the drilled hole causing the mini nitinol pushers to bend during insertion, which would allow the anchors to be pulled out and not set.
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Manufacturer Narrative
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This follow-up report is being filed to relay corrected information.
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Event Description
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It was reported that patient underwent a right wrist ligament repair on (b)(6) 2015 utilizing suture anchors.During the procedure, four anchors were attempted for use unsuccessfully as they pulled out of the patient's bone.Additional suture anchors and competitor product were used to complete the procedure.
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Search Alerts/Recalls
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