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Model Number LOW PROFILE SCREW, 1.4X7MM, CORTICAL, TI |
Device Problems
Break (1069); Entrapment of Device (1212); Difficult to Insert (1316)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 10/31/2022 |
Event Type
malfunction
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Event Description
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On 10/31/2022, it was reported by a sales representative via phone that a ar-18714-08, ar-18714-07, and a ar-18714-09 screw broke.This occurred during a phalanx fracture on (b)(6)2022 when inserting the ar-18714-08 screw it broke about 3/4 of the way, the surgeon then attempted to insert a ar-18714-09 screw to secure the plate to the bone, upon insertion the screw broke.Then a ar-18714-07 screw was used to secure the plate as it was already down, when attempting to secure the plate it broke.All broken fragments remain in the patient.The patient had very good bone quality and the sockets were prepped for insertion with a ar-18700-06 drill bit.
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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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Search Alerts/Recalls
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