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Model Number IB KIT, BC, W/ CC FT AND JUMPSTART |
Device Problem
Break (1069)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 03/18/2024 |
Event Type
malfunction
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Event Description
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On (b)(6) 2024, it was reported by a sales representative via email that both cannulate drill bits from an ar-1788j-cp biocomposite internalbrace implant system, ligament augmentation repair, with jump start dressing broke into the patient's talus.The suture passing wire also broke in the patient but was retrieved from the patient.The broken drill bits remain in the patient.This was discovered during a procedure on (b)(6) 2024.
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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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