It was reported that, during an unknown procedure, the 7mm flexible drill broke while beginning to drill the tunnel.It is unknown if a back-up device was available or if there was a delay in the scheduled surgery.No patient injuries or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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H10: h3,h6: one 7209008 drill flexible endoscopic cann 7mm, intended for use in treatment, has not been returned for evaluation.This is a six-year-old reusable device.Due to unavailability, investigation was limited.The information provided states: ¿during an unknown procedure, the 7mm flexible drill broke while beginning to drill the tunnel¿.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force applied, surgical techniques, proper care and handling.The instruction for use states: ¿do not use these instruments as levers for manipulating hard tissue or bone.Excessive force should not be applied to the instrument when manipulating soft tissue, bone, or hard objects.Misuse of these instruments may result in bent distal tips or jaws; and dull or uneven cutting edges¿.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.A review of complaints and manufacturing batch records was preformed, no complaints of this failure were found.
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