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NAVIO HANDPIECE Adverse Event — Malfunction (MDR 3010266064-2020-01545)

NAVIO HANDPIECE Adverse Event — Malfunction (MDR 3010266064-2020-01545) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: NAVIO HANDPIECE; Generic name: ORTHOPEDIC STEREOTAXIC INSTRUMENT; Manufacturer: BLUE BELT TECHNOLOGIES.

DeviceNAVIO HANDPIECE
Generic nameORTHOPEDIC STEREOTAXIC INSTRUMENT
ManufacturerBLUE BELT TECHNOLOGIES
Report number3010266064-2020-01545
Event typeMalfunction
Product problemY
Date received2020-04-27
Report sourceCOMPANY REPRESENTATIVE, FOREIG
NarrativeIT WAS REPORTED DURING A TKA DEMO PROCEDURE, THE HANDPIECE FAULTY, IT WAS NOT ABLE TO BURR. THE PROCEDURE WAS CONTINUED MANUALLY WITHOUT ANY DELAYS. NO OTHER COMPLICATIONS WERE REPORTED. NO PATIENT INVOLVED.
SourceopenFDA MAUDE (device adverse events)

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