A facility reported a surgeon used a perforator to create burr hole.Upon drilling, the perforator stopped spinning prematurely.The surgeon then tried to remove it from the patient¿s skull and it fell apart into multiple pieces.It took approximately 20 minutes to remove the remaining piece from the patient¿s skull.The surgeon eventually had to use another drill to chisel out the perforator.The manufacturer of the drill used with the perforator is an electric medtronic.According to information provided, it is unknown if perforator clicked in place in the drill, and if the recommended spring tests being performed between burr hole.Issue had no known adverse effect on patient outcome.
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The perforator (b)(6) was not returned for evaluation as the product was discarded; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
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