Model Number INTERFERENCE SCREW INSERTION KIT |
Device Problems
Break (1069); Entrapment of Device (1212)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 02/22/2022 |
Event Type
malfunction
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Event Description
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It was reported that during an anterior cruciate ligament (acl) reconstruction surgery with btb graft + fastthread interference screws, the surgeon used the interference screw insertion kit to insert the fast thread screw (9mm x 30mm).He did drill the wire beyond the depth marking relative to the black handle on the insertion kit dilator device.The surgeon withdrew the screw driver and attached the wire driver to remove the wire.The torsion must have broken the wire.Surgeon tried to pull the broken portion of the wire directly out with pliers.This portion of wire broke again resulting in the remining piece remaining in situ within the patients femur.It was decided to leave it and complete the case.The surgery was finished successfully with the same device was used anyway.It was not necessary to switch the surgical technique or do a second surgery.
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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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Manufacturer Narrative
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Complaint confirmed, even though the device was not returned, an x-ray was provided which shows what may be a fragment from a wire.It is not possible to confirm this is a fragment from the nitinol wire c15419 included in the ar-1249tk kit.
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Search Alerts/Recalls
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