ARTHREX, INC. BURR, OVAL, 12 FLUTE 5.5MM X 13CM; BURR, SURGICAL, GENERAL & PLASTIC SURGERY
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Model Number BURR, OVAL, 12 FLUTE 5.5MM X 13CM |
Device Problems
Overheating of Device (1437); Excessive Heating (4030)
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Patient Problems
Burn(s) (1757); Burn, Thermal (2530)
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Event Date 11/01/2018 |
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 during a rotator cuff repair, they were using the burr to resection 5mm of distal clavicle; they were hearing a high pitched noise so they changed the burr out to complete the case.The burr had become heated and there was a burn to the patient at the posterior portal.They used silver compound on the wound.There were no additional incisions or hospitalization required and the case was completed.
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Manufacturer Narrative
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The complaint is confirmed.After visually evaluating the picture of a patient attached to the complaint, it is concluded that the device caused damage/burn in the tissue of the patient.The cause is attributed to a supplier process and two root causes were identified: material and measurement.Material: material is considered to be a root cause as components that did not meet specification contributed to the event.Because the heat shrink recovered outer diameter and the outer tube inner diameter were oversized and undersized respectively, proper clearance did not exist between the burr components which cause the generation of heat.Measurement: measurement is considered to be a root cause due to the inadequate ""spins freely"" test which allowed nonconforming material to be accepted into inventory.
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Search Alerts/Recalls
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