Additional Manufacturer Narrative · 1
A TREND ANALYSIS CONDUCTED BY US BASED ON A COMPLAINT EVAL DID NOT REVEAL ANY STRIKING FEATURES INDICATING AN ACCUMULATIVE OCCURRENCE OF THIS TYPE OF NONCONFORMANCE. THERE HAS BEEN ONE COMPLAINT WITHIN THE PAST 5 YRS, THAT WAS SUBSEQUENTLY REPORTED AS MDR #8010877-2006-00007. HAVING CAREFULLY REVIEWED THE PRODUCTION RECORDS FOR THE LOT NUMBER AFFECTED, WE CAN CONFIRM THAT BOTH THE CORRECT MATERIAL AND COMPONENTS WERE USED AND THAT THE INSTRUMENTS ARE IN CONFORMANCE WITH THE PRODUCT SPECIFICATIONS. UPON EXAMINING THE INSTRUMENT IN QUESTION, WE FOUND THE FOLLOWING: THE SHAFT IS DEFORMED WITH ONE PART OF THE JAW HOLDER HAVING BROKEN OFF. A HARDNESS TEST PERFORMED BY US RESULTED IN A HARDNESS VALUE OF HRC 48 WHICH IS WITHIN THE SPECIFIED RANGE OF HRC 44-48. CONCLUSION: THE INSTRUMENT IS IN ACCORDANCE WITH THE SPECIFICATIONS. WE HAVE NO EXPLANATION AS TO WHAT EXACTLY THE BREAKAGE WAS CAUSED BY. DUE TO THE NATURE OF THE DAMAGES VISIBLE, OUR ASSUMPTION IS THAT THE INSTRUMENT BROKE AS A RESULT OF OVERSTRESSING - POSSIBLY CAUSED BY A LEVERING OF THE INSTRUMENT. CORRECTIVE AND PREVENTIVE ACTION: BASED ON OUR EXAMINATION OF THE INSTRUMENT, WE HAVE NO INDICATION WHATSOEVER THAT EITHER THE DESIGN, MATERIAL OR MFG PROCESS, OR ANY OTHER CIRCUMSTANCES WITHIN OUR SPHERE OF INFLUENCE, HAVE GIVEN CAUSE FOR ANY CORRECTIVE OR PREVENTIVE ACTION TO BE INITIATED BY US. NO ACTION WILL THEREFORE, BE TAKEN BY US.