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Model Number PL-PTACK |
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 09/27/2021 |
Event Type
malfunction
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Event Description
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During implantation of a clavicle plate to treat a fracture, a plate tack was used.While inserting the plate tack, the distal side broke off in the bone.Because the surgeon could not remove it, it was left implanted.
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Manufacturer Narrative
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The plate tack was inspected on its return.The tip of the tack has broken off.Approximately 0.333in was broken off the tip.The surface of the fracture shows no sign of fatigue stress.The fracture patters are consistent with a brittle fracture caused but a higher energy event like encountering dense bone or damage during shipment, or by excessive wear from multiple uses in hard bone or dropping/hitting the tack with excessive force.
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Search Alerts/Recalls
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