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Model Number FIBERTAK |
Device Problems
Loose or Intermittent Connection (1371); Device Slipped (1584)
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Patient Problem
Insufficient Information (4580)
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Event Date 07/14/2021 |
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.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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It was reported that during refixation of the labrum surgery it was 9 anchors necessary that 4 anchors did hold, the anchors did not fit through the guide sleeve or die rip out again.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.No further information received.Update, 28-jul-2021: received further information that new holes had to be drilled during surgery but the new fibertaks also did not hold.The surgery was finished successfully with pushlocks, where the surgeons had drilled new holes for.No further information received.
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Manufacturer Narrative
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After further review of this complaint it has been concluded that no serious injury occurred.
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Search Alerts/Recalls
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