A facility reported that when the mayfield disposable adult skull pins (a1083) was attached to the patient, the bone was broken through (tabula interna); the thorn/pin was too sharp.Additional information received indicates that during positioning of the patient and fixation of the skull clamp, the pin broke through the skull/fracture.Patient is currently reported as "ok", but has the fracture.There was delay of 20 minutes reported.Further additional information was received stating that "indication of surgery was op: cavernom at pinealis-region.".
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Mayfield disposable adult skull pins (a1083) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Device history record (dhr) review - lot number information has been provided; therefore, the dhr was reviewed and no anomalies that could be associated with the complaint incident was observed.Failure analysis - failure analysis cannot be completed, as the skull pin was discarded by the customer.The customer provided x-ray images which appear to show a skull fracture.However, without the return of the skull pin it cannot be confirmed if this was due to a deficiency with the skull pin.Root cause - the definite root cause cannot be identified as the device was not returned.Based on the reported complaint, probable root cause is improper placement of the skull clamp and pins or excessive force applied.This will be monitored and trended going forward.
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