It was reported that, during a navio preventative maintenance, when they ran the anspach drill for one minute, the distal tip and main body of the motor got hot after a few seconds and is extremely loud.No patient involved.No other complications were reported.
|
The anspach drill intended for use in treatment was returned for evaluation.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The evaluation followed pv0005 rev.B.The reported problem was confirmed.The drill runs extremely hot to the touch and makes a loud whining noise.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints associated with the part with the failure modes ¿overheating of device, noise, audible" and "overheating, noisy¿ identified similar events.The most likely cause of the drill overheating is mechanical damage to the drive shaft.The drill is an oem part and cannot be further disassembled to determine a root cause.Based on the investigation, no further containment or corrective action is recommended or required at this time.
|