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LEGEND DISSECTING TOOL Adverse Event — Injury (MDR 1625507-2020-00060)

LEGEND DISSECTING TOOL Adverse Event — Injury (MDR 1625507-2020-00060) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: LEGEND DISSECTING TOOL; Generic name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED); Manufacturer: MDT POWERED SURGICAL SOLUTIONS.

DeviceLEGEND DISSECTING TOOL
Generic nameDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
ManufacturerMDT POWERED SURGICAL SOLUTIONS
Report number1625507-2020-00060
Event typeInjury
Product problemY
Date received2020-04-27
Report sourceFOREIGN, HEALTH PROFESSIONAL
NarrativeREPORT CONFIRMED. EVALUATION DETERMINED THAT THE TOOL WAS RETURNED USED AND FRACTURED IN TWO PIECES. IT WAS ALSO NOTED THAT THE FRACTURE LOCATION WAS FOUND AT THE END OF THE FLUTED PORTION AND IS RELATIVELY PLANAR AND PERPENDICULAR TO THE AXIS OF ROTATION. BIOMATERIAL WAS ALSO FOUND ON TOOL. THE LIKELY CAUSE OF FAILURE WAS AN APPLIED SIDE LOAD (BENDING) TO THE TOOL WHEN IT WAS NOT ROTATING. THE US
SourceopenFDA MAUDE (device adverse events)

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