ARTHREX, INC. 3.0X130MM FIBULA NAIL, LEFT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number 3.0X130MM FIBULA NAIL, LEFT |
Device Problems
Break (1069); Physical Resistance/Sticking (4012)
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Patient Problem
Failure of Implant (1924)
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Event Date 12/23/2020 |
Event Type
Injury
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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 upon doing the initial 3.0 reaming over the flexible guide pin, the tip of the guide pin broke off in the proximal fibula.This wasn't noticed on x-ray until the implant was fixated and final x-rays were taken.The pin was pushed further up the fibula during implantation.The doctor did not want to leave the broken pin in the bone and chose to remove the hardware.In order to do so, a proximal drill hole was made at the distal end of the pin to remove the pin.This took some time.Once removed, the current nail implant was inserted to be re-implanted.The proximal talons were attempted to deploy but bone debris or something was causing the nut to not fully push out the talons.This implant was removed and another fibulock implant was opened to complete the case.Two extra incisions were made in this case because of the hardware removal.One as mentioned in the proximal fibula and the second in the medial tibia to remove the syndesmosis button.Additional information provided 1/8/2021: procedure was a fibula orif with syndesmosis.
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