ARTHREX, INC. IB KIT, BC, W/ CC FT AND JUMPSTART; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
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Model Number IB KIT, BC, W/ CC FT AND JUMPSTART |
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 06/21/2022 |
Event Type
malfunction
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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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On 6/23/2022, it was reported by a sales representative via phone that while using the cannulated drill bit from an ar-1788j-cp internal brace implant system, the tip broke off in the patient's bone.Surgeon did not remove the broken tip and was able to use the swivelock from the kit to complete the case without further issues.This was discovered during an ankle instability procedure on (b)(6) 2022.
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Search Alerts/Recalls
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