Additional Manufacturer Narrative · 1
ACCORDING TO THE INFO REC'D FROM THE DISTRIBUTOR, THE USER FACILITY REPORTED THAT THE DEVICES FAILED DURING THEIR FIRST USAGE. THE CUTTING EDGES DEFORMED CREATING A LARGE BURR. THERE WAS NO PT INJURY. THE THREE (3) INSTRUMENTS RETURNED BY THE HOSP HAD IDENTICAL EVENT DESCRIPTIONS. ACCORDING TO THE HOSP, ALL THREE DEVICES FAILED DURING SURGERY. THEY ARE REPORTED NOT TO HAVE BEEN CUTTING; APPARENTLY THE BITE WAS NOT CLEAN, AND THE PHYSICIAN HAD TO PULL ON THE INSTRUMENTS AS THEY DID NOT PRODUCE A CLEAN CUT. NONE OF THE DEVICES CAUSED ANY PT INJURY. BECAUSE THESE INSTRUMENTS ARE USED IN A VERY SENSITIVE AREA, AROUND NERVE ROOTS AND THE DURA IN THE SPINAL CORD, THE HOSP FELT THAT THERE WAS POTENTIAL FOR INJURY IN THE FUTURE. INVESTIGATION: AT THE DISTRIBUTOR'S REQUEST, SENIOR SURGICAL INSTRUMENT ENGINEER, CHECKED THE INSTRUMENT THOROUGHLY AND REVIEWED THE COMPANY'S MFG RECORDS. S&A MARTIN. KG IS A QUALIFIED MFR OF SURGICAL INSTRUMENTS WITH MANY YRS OF EXPERIENCE IN THE MFR OF KERRISON. IN FACT, THEY ARE THE MAIN PROD LINE AND CONSTITUTE APPROX 70% OF ALL INSTRUMENTS MADE. FOR THE LAST 40 YRS, KERRISON HAVE BEEN PRODUCED ANNUALLY. THIS IS THE FIRST COMPLAINT OF THE NATURE REPORTED BY MEDICAL CENTER. A THOROUGH REVIEW OF THE PRODUCTION DOCUMENTS REVEALED NO NON-CONFORMANCES, NEITHER IN MATERIALS NOR IN PROCESSES. THERE IS NO DEVIATION FROM THE CUSTOMER'S DEVICE SAMPLE AND/OR MFG SPECS. LIKE ALL INSTRUMENTS PRODUCED BY S U. A MARTIN, THESE THREE DEVICES PASSED THE 100% QUALITY AND FUNCTIONAL CONTROL TEST PRIOR TO SHIPMENT. AS PART OF THIS INVESTIGATION, HARDENING TESTS WERE PERFORMED. THE VALUES OF 46.4 HRC (RB4752), 46.5 HRC (RB4754) + 46.7 HRC (RB4755) ARE ALL WELL WITHIN THE SPECIFIED TOLERANCE RANGE FROM 43-48 HRC FOR THIS MATERIAL, MEDICAL STAINLESS STEEL 1.4021. NO MATERIAL DEFECTS COULD BE DETECTED DURING VISUAL INSPECTION. HOWEVER, THE CUTTING EDGE OF THE SLIDING PART IS CLEARLY BENT BACK (SEE PHOTOGRAPHS). THIS LEADS US TO BELIEVE THAT THE USER(S) MUST HAVE USED THE DEVICES FOR PURPOSES FOR WHICH THEY ARE NOT INTENDED. THE ROUND IMPRESSION ON THE CUTTING EDGE SEEMS TO INDICATE THAT A HARD, SEMI-CIRCULAR OBJECT MUST HAVE BEEN GRASPED (POSSIBLY A WIRE). THE ROUND IMPRESSION OF THE WIRE CAN CLEARLY BE SEEN ON THE CUTTING EDGE. CONCLUSION: THESE OBSERVATIONS AS WELL AS THE FACT THAT ALL THREE COMPLAINTS ORIGINATED IN THE SAME HOSP SEEMS TO INDICATE THAT THE INSTRUMENTS WERE MISUSED. THE HOSP SHOULD REVIEW AND, IF NECESSARY, IMPLEMENT REVISIONS TO THEIR PROCEDURES REGARDING REPROCESSING AND FUNCTION-TESTING SURGICAL DEVICES PRIOR TO REUSE. SINCE THE REVIEW OF THE PRODUCTION DOCUMENTS DETERMINED THAT ALL APPLICABLE SPECS HAVE BEEN MET SINCE OUR TREND ANALYSIS REFLECTS NO PROBLEM WITH THIS DESIGN, NO CAPA ACTION IS REQUIRED.