Additional Manufacturer Narrative · 1
ACCORDING TO THE HOSP THE INSTRUMENT FELL APART DURING A SPINAL FUSION PROCEDURE. NO PT INJURY WAS REPORTED. VISUAL INSPECTION UPON RECEIPT OF THE INSTRUMENT BY THE DISTRIBUTOR, DETERMINED THAT THE TOP RAIL OF THE RONGEUR WAS NOT ASSEMBLED TO THE BODY OF THE INSTRUMENT. NO PIECES OF THE INSTRUMENT WERE MISSING. INVESTIGATION: AT THE DISTRIBUTOR'S REQUEST,PRODUCTION MGR AND QUAL MGMT REP, CHECKED THE INSTRUMENT THOROUGHLY AND, IN ADDITION, REVIEWED THE CO'S MFG RECORDS. THE INSTRUMENT IN QUESTION WAS MFG WITH LOT NO. 971366 AS ONE OF 15 PCS. ON 5/29/02 ALL 15 PCS. WERE DELIVERED TO THE DISTRIBUTOR. OUR COMPUTER SYSTEM THAT WAS INTRODUCED IN DECEMBER 2002 ALLOWS US TO TRACE BACK DELIVERY OF THIS ITEM. TOGETHER WITH THIS COMPLAINT, A PRACTICALLY IDENTICAL ONE (FROM SAME HOSP/SAME PRODUCT FAMILY/ SAME COMPLAINT DESCRIPTION) WAS RECEIVED WITH THE DISTRIBUTOR'S COMPLAINT FOR WHICH A SEPARATE INVESTIGATION REPORT IS BEING SUBMITTED. TO DATE, THESE ARE THE ONLY TWO INCIDENTS THAT HAVE COME TO OUR ATTENTION. A THOROUGH REVIEW OF OUR PRODUCTION DOCUMENTS REVEALED NO NON-CONFORMANCES IN MATERIALS, MFG PROCESSES OR ANY DEVIATIONS WHATSOEVER WHEN COMPARING THE DEVICE(S) WITH THE MASTER SAMPLE AND/OR ENGINEERING DRAWING. THEY PASSED THE 100% QUALITY AND FUNCTIONAL CONTROL PRIOR TO DELIVERY. AS PART OF THIS INVESTIGATION WE PERFORMED A HARDENING TEST RESULTING, WELL WITHIN THE SPECIFIED TOLERANCE RANGE FOR THIS MATERIAL, MEDICAL STAINLESS STEEL. NO MATERIAL DEFECTS COULD BE DETECTED DURING VISUAL INSPECTION. THE FUNCTIONAL TEST AFTER INSTRUMENT RE-ASSEMBLY REVEALED NO DEFECTS. WE NOTICED DURING VISUAL INSPECTION THAT THE T-SHAPED SLIDING BAR, WHICH IS LOCATED IN THE SLIDING PART OF THE SHAFT, IS WORN (SEE PHOTOGRAPH). THE HOSP SHOULD BE INSTRUCTED TO VISUALLY INSPECT THE DEVICE AFTER REPROCESSING IN ORDER TO DETECT RESIDUAL CONTAMINATION AND/OR INSTRUMENT DAMAGE. EVERY DEVICE MUST BE FUNCTION-TESTED PRIOR TO REUSE. IF THAT HAD BEEN DONE, DISASSEMBLY DURING PROCEDURE WOULD NOT HAVE HAPPENED. INSTRUMENTS THAT ARE NOT CLEAN AND/OR DO NOT MEET THEIR FUNCTIONAL REQUIREMENTS, MUST BE REMOVED FROM THE TRAY IMMEDIATELY. MFR DOES NOT ASSUME RESPONSIBILITY FOR MODIFICATIONS AND UNAUTHORIZED REPAIRS TO THEIR INSTRUMENTS AND WILL REJECT ALL ENSUING WARRANTY CLAIMS.