DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING APPLICATION OF THE BONE GRAFT HARVESTING SET, A BONE DOWEL WAS TAKEN FROM THE ILIAC CREST. THE K-WIRE WAS INSERTED AND LIGHT HAMMER BLOWS WITH A SMALL HAMMER WERE GIVEN TO ADVANCE THE TREPHINE INTO THE BONE AS THE NORMAL TWISTING INSERTION WAS NOT POSSIBLE. AFTER INSERTION TO THE CORRECT DEPTH THE HANDLE WAS TWISTED TO REMOVE THE TREPHINE WITH THE BONE DOWEL. AT THIS TIME THE TREPHINE SHEARED OFF. THE PART THAT WAS STUCK IN THE ILIAC CREST BROKE INTO LITTLE PIECES UPON REMOVAL. ALL PIECES WERE REMOVED AND X-RAY WAS USED TO CHECK THIS INTRA-OPERATIVELY. NO HARM WAS DONE TO THE PATIENT; THE SURGERY WAS PROLONGED FOR TWENTY MINUTES TO REMOVE ALL PARTS OF THE INSTRUMENT. THIS WAS THE THIRD TIME THE DEVICE WAS BEING USED. THE HANDLE WAS NOT AFFECTED AS ONLY THE TREPHINE ATTACHED TO THE HANDLE BROKE. THE HANDLE WAS USED SUCCESSFULLY WITH OTHER TREPHINES DURING THE PROCEDURE. THIS IS REPORT 1 OF 1 FOR (B)(4).
N
Patient 1
DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(4). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
N
Patient 1
(B)(6). NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS COMPLETED: THE TREPHINE WAS RECEIVED BROKEN. THE INVESTIGATION HAS SHOWN THAT THE TREPHINE IS BROKEN AS COMPLAINED. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THIS INSTRUMENT WAS MANUFACTURED IN OCTOBER 2012 ACCORDING TO THE SPECIFICATIONS. NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT WERE FOUND. THE TREPHINE ATTACHMENT IS MADE FROM STAINLESS STEEL (HARDENED AND TEMPERED) AND IS MANUFACTURED ACCORDING TO THE ISO NORM 7153. IN ADDITION THE HARDNESS PARAMETERS WERE CHECKED RANDOMLY AT THE TIME OF MANUFACTURING. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES AND IT IS LIKELY THAT CONTACT WITH OTHER METALLIC MATERIALS (E.G. K-WIRE) LED TO A MECHANICAL OVERLOADING AND HENCE TO THE FRACTURE OF THE INSTRUMENT. THE HARDNESS WAS MEASURED AT THE TIME OF THE MANUFACTURING AND WAS FOUND TO BE GOOD. THE DIMENSIONS CANNOT BE VERIFIED DUE TO THE DAMAGE. THE TYPE AND EXTENT OF DAMAGE INCURRED INDICATE THAT THIS COMPLAINT WAS CAUSED BY WRONG HANDLING. NO INDICATION FOR MATERIAL OR DESIGN RELATED ISSUE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.