A facility reported: "during the surgical procedure, when perforator (id 261222) is assembled in the coupling, it is evident that it is unadjusted (loose).The surgeon performs the adjustment manually.When performing the burr perforation, the drill does not perform the blocking when passing the bone table and continues until the dura of the patient." no patient injury reported and the event led to less than 30 minutes surgical delay.The drill was an electric pidrive engine (stryker).The drill clicked into place on the drill and it was heard when assembling it with the coupling and the bit.Recommended resource tests being performed between each hole and several tests were carried out at the time of finishing assembling the coupler with the motor and configuring the console.The surgeon performed the craniotomy at a 90 degree angle.At all times, they tried to maintain the angle, however the drill became dislodged from the coupling at the beginning of the craniotomy process and had to be rearranged.They confirmed that constant pressure was maintained at all times.
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The perforator (id 261222) was returned for evaluation.Device history record (dhr)- there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the perforator unit was inspected using the unaided eye.Product had a destroyed eo label, likely from getting wet, but no other observed anomalies.The "ifu" testing procedure was performed with no observed anomalies.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release.The unit was found to perform as intended and fulfilled the acceptance criteria.Root cause analysis- the root cause is undetermined and was unable to be confirmed in the complaint evaluation.The potential causes of failure include: user misuse.
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