ARTHREX, INC. FIBULOCK IMPLANT SYSTEM, STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number FIBULOCK IMPLANT SYSTEM, STERILE |
Device Problems
Break (1069); Failure to Advance (2524); Material Twisted/Bent (2981)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 03/04/2021 |
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.
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Event Description
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It was reported that the long flexible wire from the ar-8973ds fibulock implant system was introduced and advance up the fibula.When the 3.2mm reamer was introduced and advanced up the fibula, the device came to a hard stop.When attempting to advance the 3.2mm reamer up the fibula further, the flexible wire that was being reamed over broke in half.The broken flexible wire was left in the fibula and the ar-8973l-30-130 fibulock nail was inserted per technique guide.The proximal tip of the fibulock nail came into contact with the broken end of the wire and as the fibulock nail passed by the broken wire, the proximal tip of the fibulock bent.The fibulock nail and flexible wire were both left in the fibula as the fracture was reduced and the doctor did not have a problem leaving it in the patient.
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