DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE NOSE OF THE PLATE WAS BROKEN. THIS PRODUCT WAS BROKEN IN THE OPERATION ON (B)(6) 2013. WHEN THE SURGEON TRIED TO BEND THE PLATE BY THE NOSE WITH BENDING/CUTTING PLIERS, THE NOSE BROKE. AFTER THE OPERATION, THE SALES REP VISITED THE HOSPITAL FOR THE FOLLOW-UP AND BECAME AWARE OF THE ISSUE ON (B)(6) 2013. THE SURGEON THOUGHT IT MAY HAVE BEEN CAUSED DUE TO METAL FATIGUE SINCE IT OCCURRED DURING THE BENDING. THERE WAS NO EFFECT ON THE PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
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Patient 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. PLACEHOLDER.
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Patient 1
AN INVESTIGATION WAS CONDUCTED AND IT STATES THE NOSE WAS BROKEN AWAY ON THE SMALLEST CROSS-SECTION OF MATERIAL. THE PRESENT PLIERS WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED. THE THICKNESS OF THE ARTICLE WAS MEASURED AND FOUND TO BE OUT OF SPECIFICATIONS ON ONE SECTION. AN INTERNAL INVESTIGATION WAS CONDUCTED. THE BREAKAGE OF THE NOSE OCCURRED DUE TO THE POINTED OUT CROSS-SECTION.(B)(4)