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Patient 1
THE EXACT ROOT CAUSE IS UNDETERMINED. BOTH DEVICES WERE SUBMITTED TO OSTEOMED ON 05/30/2013 UNDER (B)(4). THE SRO DOCUMENTS THAT 450-0777, S/N (B)(4) OVERHEATS. THE OTHER 450-0777 DEVICE DOES NOT INDICATE OVERHEATING. IT STATES THAT THE MODULE SHUT DOWN THE CONSOLE. THOUGH IT APPEARS THAT THE DEVICE DOCUMENTED AS OVERHEATING WAS USED DURING THIS CASE, THAT INFORMATION IS NOT SPECIFICALLY KNOWN. THE DIAGNOSTIC OF BOTH UNITS SHOW THAT THE DISTAL BEARING WAS BROKEN. BEARINGS WILL FAIL WHEN THE ACCUMULATION OF DEBRIS WITHIN THE DEVICE REACHES A LEVEL THAT THEY NO LONGER SPIN FREELY. THIS CAUSES HEAT TO BUILD UP AND EVENTUALLY EITHER BREAK OR SEIZE UP AND STALL (SHUT DOWN) THE CONSOLE. THE CONSOLE IS EQUIPPED WITH A OVER-CURRENT PROTECTION AND AUTOMATICALLY SHUTS-DOWN WHEN THE CURRENT DRAWN BY MOTOR UNIT AN MODULE GOES OVER 5-6 AMPS. THE DIAGNOSTIC OF THESE DEVICES SHOW THAT BOTH EXHIBITED BEARING FAILURE. PER THE RESULTS OF IN INTERNAL CAPA, BEARING FAILURES CAN BE CAUSED BY THE FOLLOWING CONDITIONS: ? FRICTION DUE TO VIBRATION OR DEBRIS, OR EXCESSIVE WEAR ? POOR/INEFFECTIVE MAINTENANCE AND LUBRICATION ? OUT OF ROUND, OR EXCESSIVELY WORN FRONT HOUSING. THE CORRECTIVE ACTION RECOMMENDATIONS CONCERNING THIS CAPA WERE IMPLEMENTED IN 2014. THESE DEVICES WERE MANUFACTURED PRIOR TO 2014 - 2002 AND 2003. THE REVIEW OF THE DHRS DID NOT IDENTIFY ANY NON-CONFORMANCES CONCERNING THIS ISSUE. NO NCRS WERE IDENTIFIED FOR THIS ISSUE. THE REVIEW OF COMPLAINTS IDENTIFIED THREE SIMILAR ISSUES OF PATIENT BURN. HOWEVER, TWO ARE INCLUDED IN THE CAPA. THE SERIES III STRAIGHT DRILL IS A REUSABLE DEVICE WITHIN THE OSTEOPOWER PRODUCT FAMILY. THE REVIEW OF THE OSTEOPOWER HANDPIECE SYSTEM PRODUCT INFORMATION AND INSTRUCTIONS FOR USE (030-1106) PROVIDES INSTRUCTIONS FOR MAINTAINING DEVICE EFFECTIVENESS AND CLEANING. IT ALSO INSTRUCTS THE USER TO REVIEW THE OSTEOPOWER SURGICAL HANDPIECE SYSTEM OPERATING INSTRUCTIONS AND MAINTENANCE MANUAL (030-1179) PRIOR TO USE. A REVIEW OF THE MANUAL SHOWS THAT OSTEOMED RECOMMENDS THAT ALL OSTEOPOWER HANDPIECE COMPONENTS BE EXAMINED EVERY TWELVE (12) MONTHS FOR PREVENTIVE MAINTENANCE. THE SERVICE HISTORIES FOR THESE DEVICES SHOW THAT THEY HAD NOT BEEN RETURNED TO OSTEOMED SINCE 2010. MORE SPECIFIC TO 450-0777, THE USE OF THE 450-0777 WITH CONTAMINATED AND/OR WORN BEARINGS MAY RAPIDLY GENERATE HEAT AND CAUSE PATIENT INJURY. THE STRAIGHT DRILL MUST BE THOROUGHLY CLEANED AND LUBRICATED AFTER EACH USE TO PREVENT BEARING CONTAMINATION. FAILURE TO CLEAN AND LUBRICATE PROPERLY, AND RETURN TO OSTEOMED FOR PERIODIC MAINTENANCE CAN LEAD TO CONTAMINATED BEARINGS THAT CAN FAIL AND GENERATE EXCESSIVE HEAT.. PER THE OSTEOPOWER 2I SYSTEM RISK ASSESSMENT AND FMEA FILE, THIS TYPE OF FAILURE MODE HAS A RISK LEVEL SCORE OF LOW. THIS ISSUE WILL BE MONITORED THROUGH ROUTINE TRENDING.