A bhr curved dysplasia drill 3.2mm (part number 90127619, batch number 6081100001) has been received for investigation.It was reported that the instrument broke while drilling inside the patient.No delay reported.No additional patient injuries reported.A review of the complaint history for the bhr dysplasia drill 3.2mm was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the dysplasia drill 3.2mm.Due to the age of the instrument, the dhr for this instrument is not available.Therefore, the dhr for this device cannot be reviewed.However, the released instrument involved would have met manufacturing specifications at the time of production.A risk management review was performed.No additional risks were identified as result of the reported event.No further actions are required at this time.Visual inspection was performed on the instrument.Scratches could be seen across the instrument consistent with surgical use.Visual inspection confirms that the device has snapped into two pieces and cannot function, this confirms the reported complaint.A functional evaluation of the instrument was not performed as it was broken.Bhr surgical technique 04727 v2 45670103 revc 01/18 states, "examine instruments for wear or damage before use.While rare, intra-operative instrument breakage can occur.Instruments that have experienced excessive use or force may be susceptible to breakage".The root cause of the reported issue could not be determined conclusively.A potential root cause is general wear and tear which would not have existed on the instrument when originally produced and inspected by smith & nephew.The returned instrument part cannot be repaired and will be retained.
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