ON 5/24/2017 INTEGRA INVESTIGATION COMPLETED. MANUFACTURE DATE UNKNOWN. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - ONE RHOTO HOOK RETURNED IN USED CONDITION, SHOWING MINIMAL WEAR AND A BROKEN TIP. WITHOUT KNOWING HOW MUCH PRESSURE WAS USED TO THE TIP WHEN IN USE, THE CAUSE IS UNDETERMINED. THIS TYPE OF DAMAGE IS USUALLY THE RESULT FROM IMPROPER USAGE. THE COMPLAINT REPORT IS CONFIRMED; DAMAGED/WORN. DEVICE HISTORY EVALUATION - NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: NONE. VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE. HEALTH HAZARD ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: THERE IS NO APPLICABLE ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY/CORRECTIONS: NONE. EVALUATION HISTORY: NONE. CONCLUSION: THE ROOT CAUSE HAS NOT BEEN IDENTIFIED AS A WORKMANSHIP OR MATERIAL DEFICIENCY.
D
Patient 1
CUSTOMER INITIALLY REPORTS THAT DOCTOR WAS PERFORMING A ADCF USING THE RHOTON HOOK AND FELT THE TIP BREAK OFF. HE SEARCHED THE PATIENT CAVITY TO FIND THE BROKEN PIECE AND COULD NOT FIND IT. HE THINKS IT MAY HAVE BEEN SUCKED UP BY THE SUCTION THEY WERE USING BUT ISN'T POSITIVE. THE REST OF THE CASE WAS COMPLETED WITHOUT ADDITIONAL INCIDENCE. ON (B)(6) 2017 DOCTOR WAS PERFORMING A CERVICAL 3-7 ANTERIOR CERVICAL DISCECTOMY FUSION. X-RAY WAS TAKEN. NO HARM DONE.