MICA BURR 2 X 12MM STERILE MICA

Description of Event or Problem

IT WAS REPORTED THAT "INDEED, THE DRILL IS NOT EFFECTIVE ON A VERY HARD BONE AND CAUSES BURNS OF THE SKIN EVEN IN NORMAL CONDITION AFTER 2 MINUTES OF USE WHICH MAY REQUIRE THE EXCISION OF THE SKIN".

Additional Manufacturer Narrative

DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE DISCARDED.

Description of Event or Problem

IT WAS REPORTED THAT "INDEED, THE DRILL IS NOT EFFECTIVE ON A VERY HARD BONE AND CAUSES BURNS OF THE SKIN EVEN IN NORMAL CONDITION AFTER 2 MINUTES OF USE WHICH MAY REQUIRE THE EXCISION OF THE SKIN".

Additional Manufacturer Narrative

THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. THE DEVICE INSPECTION WAS NOT POSSIBLE AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. THE OPERATIVE TECHNIQUE INSTRUCTS USER THAT: ¿BURRS WERE DESIGNED TO BE USED AT 6000 RPM. HIGHER ROTATION COULD CAUSE INCREASED RISK OF BONE NECROSIS OR SOFT TISSUE DAMAGE. IT IS IMPORTANT TO ROTATE AND LIFT WHILE CUTTING TO BOTH PREVENT ANY THERMAL INJURY TO THE SKIN/SOFT TISSUES AND PREVENT PLANTAR EXTENSION OF THE OSTEOTOMY ON THE NEAR CORTEX. IMAGINE THE SKIN PORTAL AS THE FULCRUM POINT FOR ROTATION.¿ MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF DEVICE IS RETURNED OR ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE REASSESSED.