Additional Manufacturer Narrative · 1
EVENT DESCRIPTION: AS WE WERE INFORMED BY THE DISTRIBUTOR THE SURGEON GRIPPED A 5/0 SUTURE AND THE TC INSERT BROKE. THE BROKEN PIECE OF THE INSERT WAS NOT RETURNED WITH THE INSTRUMENT FOR EVAL. THERE WAS NO PT INJURY REPORTED. THIS INCIDENT OCCURRED AT THE HOSP IN ANOTHER COUNTRY. THE INSTRUMENT IN QUESTION WAS THOROUGHLY CHECKED BY CEO AND QUALIFIED MASTER OF SURGICAL INSTRUMENTS. PRODUCT LOT# 1261860 WAS MANUFACTURED IN JUNE 2006 AND DELIVERED TO THE DISTRIBUTOR ON JULY 10, 2006. WE ARE ABLE TO TRACE BACK DELIVERY FOR THIS ARTICLE UNTIL JANUARY 2003. SINCE THEN WE HAVE DELIVERED A LARGE QUANTITY OF THIS ARTICLE TO THE DISTRIBUTOR WITHOUT RECEIVING A COMPLAINT REGARDING A BROKEN TC INSERT SO FAR. THE PRODUCTION DOCUMENTS PROVE THAT THE INSTRUMENT WAS MANUFACTURED IN ACCORDANCE WITH THE GIVE PRODUCTION SPECS. THE FRACTURE WAS INSPECTED VISUALLY. OVERALL CONDITION OF THE TC INSERT WAS FOUND TO BE COMPLETELY WORN OFF. CONCLUSION: NO DEFINITE CONCLUSION CAN BE DRAWN, BUT BASED ON OUR VISUAL INSPECTION WE ASSUME THAT A HAIRLINE CRACK IN THE TC INSERT CAUSED THE BREAKAGE. DUE TO THE HIGH HARDNESS OF THE INSERT (1300 +/- 50 HV 10) AND THE BIG DIFFERENCE IN HARDNESS BETWEEN THE INSERT AND THE STAINLESS STEEL OF THE NEEDLE HOLDER A HAIRLINE CRACK CAN OCCUR IN THE CASE OF MISUSE (IMPACT ON THE INSTRUMENT E.G. IF IT IS DROPPED ON THE FLOOR OR APPLYING TOO MUCH FORCE). SINCE THIS EVAL INDICATES NO DEFECT OF MATERIAL, NO DEFECT IN DESIGN OR ANY DEFECT IN MFG, WE FEEL THAT NO CORRECTIVE MEASURE IS TO BE TAKEN ON OUR PART. WE WISH TO POINT OUT, THAT IF THE PART THAT BROKE OFF, REMAINED INSIDE THE PT, THE PT HAS TO BE MADE AWARE OF POSSIBLE RISKS IN THE CASE OF ANY FUTURE MRIS. IN ADDITION WE RECOMMEND TO REPLACE THE TC INSERTS BEFORE THEY ARE COMPLETELY WORN OFF.