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 11/09/2018 |
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 the oval burr, ar-8550obt, was being used in a case and shortly after it began spinning, the burr became hot and burned the patient's skin.Additional information provided (b)(6) 2018: this event occurred while the surgeon was performing a subacromial decompression during a shoulder arthroscopy procedure.The patient was burned on their shoulder; however, no photos were captured.Additional information provided (b)(6) 2018: a photo was taken at the patient's follow-up appointment.
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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 device was not returned for evaluation.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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