ARTHREX, INC. FIBULOCK IMPLANT SYSTEM, STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number FIBULOCK IMPLANT SYSTEM, STERILE |
Device Problem
Temperature Problem (3022)
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Patient Problem
Burn, Thermal (2530)
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Event Date 11/21/2018 |
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 requested/is expected but has not returned for evaluation.The 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 as the surgeon was drilling the distal portion of the fibula with the 6.2 reamer, the in6300 double sided tissue protector heated up while drilling, and the patient's tissue was burned.The rep reported that the bone quality was hard.Additional information received on 12/05/2018: the rep stated that the 6.2 reamer being used was from ar-8973ds (lot: 10239936).The rep stated that the tissue was in contact with the in6300 double sided tissue protector, and as the surgeon was drilling with the 6.2 reamer, the tissue protector heated up and burned the contacted skin.The rep reported that they are unaware of the size or appearance of the burn mark.The rep stated that they were made aware of the incident at the end of the procedure.The rep stated they do not have any information as to how the burn is being treated.It was confirmed that an arthrex handpiece was not being used.The rep confirmed that the patient did not have to stay overnight.
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Search Alerts/Recalls
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