Additional Manufacturer Narrative · 1
INVESTIGATION: AT THE DIST'S REQUEST, DIR OF PRODUCTION AND GEN MGR, THOROUGHLY CHECKED THE AFFECTED INSTRUMENT IN THE CO'S IN-HOUSE TESTING DEPT: THE SUBJECT INSTRUMENT WAS MFG IN A LOT OF 99 PCS. ON DECEMBER 20, 2005 AND DELIVERED TO THE DISTRIBUTOR ON DECEMBER 22, 2005. SINCE 2004, WHEN PRODUCTION OF THIS DEVICE COMMENCED, A TOTAL OF 2,478 INSTRUMENTS WERE SHIPPED TO THE DISTRIBUTOR (352 PCS IN 2004, 973 PCS IN 2005, 771 PCS IN 2006 AND 282 PCS TO DATE IN 2007). A THOROUGH REVIEW OF HEBU'S PRODUCTION RECORDS REVEALED THAT NO NON-CONFORMANCES IN SPECIFIED MATERIALS OR PRODUCTION PROCESSES OCCURRED DURING THE MFR OF THIS LOT, AND THAT THE DEVICE AGREED IN ALL RESPECTS WITH THE DESIGN SPECIFICATIONS (MASTER SAMPLE) REC'D FROM THE DISTRIBUTOR. THE HARDENING PROTOCOL CONFIRMED THAT THE MEASURED HARDNESS OF 43,2 HRC (AVERAGE VALUE) TO BE WITHIN THE TOLERANCE RANGE SPECIFIED FOR SURGICAL STAINLESS STEEL 1.4021 (AISI 420), I.E. HRC 40-48. INITIATION OF CAPA ACTION: THE SAME DEVICE MODEL WAS RETURNED TWICE BEFORE WITH A SIMILAR COMPLAINT (S. MFR MEDWATCH REPORT #'S 9611112-2006-00001, SUBMITTED ON MAY 17, 2006 AND 9611112-2007-00001, MAILED ON MARCH 23, 2007). EVEN THOUGH, WE STILL HOLD THAT THE TIP CAN BREAK ONLY WHEN THE DEVICE IS USED OTHER THAN INTENDED, A CAPA ACTION WAS INITIATED AFTER THE SECOND REPORTABLE INCIDENT TO FURTHER REDUCE THE RISK OF A TIP BREAKING OFF. INSTEAD OF COMPLETELY SERRATING THE MOUTH PIECES, SERRATION WILL NOT STOP ABOUT (1) CM BEFORE THE END OF EACH TIP. THIS WILL SIGNIFICANTLY STRENGTHEN THE DEVICE TIP WHEN USED FOR OTHER PURPOSES (SUCH AS GRASPING A BONE WITH THE TIPS RATHER THAN HOLDING IN CLAMP-LIKE AS INTENDED, FOR INSTANCE WHEN USING THE CLAMP LIKE A REPOSITIONING FORCEPS), BUT WITHOUT REDUCING THE SAFETY AND EFFECTIVENESS OF THE DEVICE FOR ITS BONE HOLDING INDICATION. THE PROTOTYPE OF THE SUGGESTED DESIGN CHANGE HAS BEEN SUBMITTED TO THE DISTRIBUTOR ON MAY 8, 2007, AND WAS APPROVED FOR ALL FUTURE PRODUCTION ON JUNE 15, 2007. EFFECTIVE IMMEDIATELY, THERE WILL BE NO MORE DELIVERIES OF THE PREVIOUS VERSION. CONCLUSION: NORMALLY, NO LATER CONTRACTION OCCURS AT THE FRACTURE LOCATION. HOWEVER, WHEN MISUSING THE INSTRUMENT, I.E. WITH LEVERING, A FRACTURE OF THE SERRATED JAW IS POSSIBLE. THE TRANSFER OF THE DESIGN CHANGE TO PRODUCTION SHOULD REDUCE THE RISK OF FUTURE TIP BREAKAGE TO AN ABSOLUTE MINIMUM. HEBU WILL CLOSELY MONITOR FUTURE COMPLAINTS ON THE LEWIN BONE HOLDING CLAMP 7, TO ASSURE THE EFFECTIVENESS OF THIS CAPA ACTION.