Additional Manufacturer Narrative · 1
INESTIGATION: THE INSTRUMENT WAS THOROUGHLY CHECKED AND EVALUATED ON OUR BEHALF AT (DISTRIBUTOR'S PURCHASING OFFICE) BY SAFETY REP AND SENIOR INSTRUMENT ENGINEER AS WELL AS BY DIR: BY MEANS OF THE LOT # 2230680 WHICH IS ETCHED ON THE INSTRUMENT AND DISTRIBUTOR'S LOT NUMBER DATA BASE, DELIVERY CAN BE TRACED BACK AS FOLLOWS: THE INSTRUMENT IN QUESTION WAS MFG IN A LOT OF 440 PCS AND DELIVERED TO THE DISTRIBUTOR IN 2005. WE ARE ABLE TO TRACE BACK DELIVERIES UNTIL DECEMBER 31, 2002 AND SINCE THEN, A LARGE QUANT OF THIS ARTICLE HAS BEEN DELIVERED TO THE DISTRIBUTOR WITHOUT RECEIVING A COMPLAINT OF THIS NATURE. UPON DELIVERY OF THE INSTRUMENTS IN 2005, THEY WERE THOROUGHLY CHECKED AT DISTRIBUTOR'S INCOMING GOODS INSPECTION, IN ORDER TO FULFILL FOLLOWING CRITERIA: CORRECT DESIGN, ETCHING, MEASUREMENTS, SURFACE QUALITY, AND OVERALL PERFORMANCE. IT WAS ALSO CHECKED, THAT THERE WERE NO CRACKS OR SHARP EDGES. WITH A DELIVERY OF 440 PCS, A TEST QUANTITY OF 50 PCS WAS CHECKED. UPON RECEIPT OF THIS INSTRUMENT FOR EVAL, A HARDNESS TEST WAS PERFORMED AT DISTRIBUTOR, RESULTING IN A VALUE OF 47.9 HRC, WHICH IS WELL WITHIN THE SPECIFIED TOLERANCE RANGE OF 44 - 48 HRC FOR THIS MATERIAL. 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. NO MATERIAL DEFECTS COULD BE DETECTED DURING VISUAL INSPECTION. THE VISUAL INSPECTION, HOWEVER, REVEALED THAT THERE IS A CRACK BETWEEN THE REMAINING JAW PART AND THE BOX-LOCK AS WELL AS STRESS CRACK CORROSION (PLEASE SEE FOLLOWING PICTURES). CONCLUSIONS: BASED ON OUR ABOVE FINDINGS WE ARE OF THE OPINION THAT EITHER OVERSTRESSING DUE TO MISUSE/ABUSE OF THE INSTRUMENT BY THE ENDUSER RESULTED IN THE BREAK OR THAT THE BREAK COULD BE A RESULT OF THE STRESS CRACK CORROSION. AS TO THE STRESS CRACK CORROSION, PLEASE FIND FOLLOWING GENERAL INFO (REFERENCE: RED BROCHURE "PROPER MAINTENANCE OF INSTRUMENTS 8TH REVISED EDITION, PUBLISHED BY THE WORKING GROUP INSTRUMENT PREPARATION").