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QUICKSET 1PC FLEX DRILL BIT 25 Adverse Event — Malfunction (MDR 1818910-2020-11343)

QUICKSET 1PC FLEX DRILL BIT 25 Adverse Event — Malfunction (MDR 1818910-2020-11343) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: QUICKSET 1PC FLEX DRILL BIT 25; Generic name: DRILLS (BITS, SLEEVES, GUIDES) : DRILLS; Manufacturer: DEPUY ORTHOPAEDICS INC US.

DeviceQUICKSET 1PC FLEX DRILL BIT 25
Generic nameDRILLS (BITS, SLEEVES, GUIDES) : DRILLS
ManufacturerDEPUY ORTHOPAEDICS INC US
Report number1818910-2020-11343
Event typeMalfunction
Product problemY
Date received2020-04-27
Report sourceCOMPANY REPRESENTATIVE, HEALTH
NarrativeDEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY AS NOT SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES C
SourceopenFDA MAUDE (device adverse events)

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