Report inclusive.No evaluation was performed as the device was not returned.This dm0010faa perforator with lot number 101/17 was m anufactured by micromar.Device history record was reviewed by micromar and per their report, all the processes were executed according to what was planned and validated.There were no observations or nonconformities during the manufacturing process.Multiple warnings are included in the easydrill cranial perforator ifu manual including: it is essential to keep the drill perpendicular (90°) at the predetermined point of the skull to be drilled, as an excessive deviation from perpendicularity may cause the product to fail and lead to serious patient injury.Select a drill bit suitable for the bone thickness.This prevents the drill from tearing the bone or brain tissue (similar effect when the bit is not positioned at 90°).If the components of the easydrill cranial perforator become loose during trephination, discontinue use.The drill can cut or tear the dura mater when it unlocks.Check some conditions before performing the procedure, such as the existence of adhering dura mater or other anomalies adjacent to the drilling site.We will continue to monitor this complaint type for trends.Physicians:(b)(6).If information is provided in the future, a supplemental report will be issued.
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