Additional Manufacturer Narrative · 1
AS REQUESTED THE INSTRUMENT WAS THOROUGHLY CHECKED. PLEASE FIND FOLLOWING OUR RESPECTIVE FINDINGS: THE PRODUCTION DOCUMENTS OF THIS LOT SHOW NO DEVIATIONS AS TO GIVEN SPECIFICATIONS FOR THE MANUFACTURING OF THIS ARTICLE. NEITHER ANY DISCREPANCIES IN THE MEASURES NOR ANY KIND OF DISCOLORATION COULD BE FOUND. IN THE PAST 5 YEARS WE HAVE DELIVERED THIS TYPE OF INSTRUMENT TO THE DISTRIBUTOR, FROM WHOM WE RECEIVED ONE OTHER COMPLAINT OF THIS NATURE. ALTHOUGH MANUFACTURING A TOTAL QUANTITY OF MORE THAN 1000 PCS. OF THIS ARTICLE DURING THIS PERIOD WE HAVE NOT BEEN NOTIFIED BY ONE OF OUR OTHER CUSTOMERS THAT THERE HAS BEEN ANY COMPLAINTS. WE TRIED TO RE-ENACT THE POSSIBLE COURSE OF EVENTS BY BENDING A SHAFT UNTIL IT HAD A KINK, WHEN RE-ADJUSTING THE SHAFT IT BROKE AND BORE EXACTLY THE SAME TRACES IN THE AREA OF THE BREAK AS THIS INSTRUMENT. PERFORMING THIS TEST STRONG FORCE HAD TO BE APPLIED TO MAKE THE SHAFT BREAK. THE VISUAL INSPECTION OF THE INSTRUMENT SHOWED, THAT THE RUST, WHICH THE CUSTOMER SAID WAS OBSERVED ON THE INSIDE OF THE SHAFT, COULD NOT BE FOUND. THE FRACTURE JOINT IS METALLIC BRIGHT (PLEASE SEE ALSO BELOW PICTURES). ON THE SIDE OF THE HANDLE DISCOLORATIONS CAN BE FOUND IN THE INNER AREA. THESE DISCOLORATIONS, HOWEVER, HAVE NOTHING TO DO WITH CORROSION. THIS KIND OF DISCOLORATION APPEARS WHEN THE SHAFT IS HARD-SOLDERED TO THE HANDLE. CONCLUSION: THE EXACT CAUSE OF THE DAMAGE CANNOT BE CONCLUSIVELY DETERMINED. AS PER OUR EXPERIENCE AND AFTER PERFORMING ABOVE DESCRIBED TEST WE ARE OF THE OPINION THAT THIS TYPE OF DAMAGE IS CONSISTENT WITH SOME USE OF STRONG FORCE WHICH RESULTED IN THE BREAKING OF THE SHAFT. HOWEVER, WE WISH TO POINT OUT, THAT INSTRUMENTS USED FOR MINIMAL INVASIVE SURGERY ARE MORE DELICATE AND CAN BE DAMAGED BY USING TOO MUCH FORCE. ESPECIALLY WITH A MYOMA SCREW, WHICH IS INTENDED FOR BEING STRESSED BY TWISTING OR PULLING, A BREAK CAN OCCUR, WHEN IT IS USED AS A LEVER. AS MENTIONED BEFORE MORE THAN 1000 PCS. OF THIS ARTICLE HAVE BEEN MANUFACTURED FOR THE LAST 5 YEARS WITHOUT BEING NOTIFIED OF ANY COMPLAINTS RESPECTIVELY BREAKS BY ONE OF OUR OTHER CUSTOMERS. WITH REGARD TO THE CUSTOMER MENTIONED IN HIS REPORT THAT THE INSTRUMENT IS DESIGNED TO BREAK AT THE END OF THE SHAFT, WE WISH TO POINT OUT THAT THE INSTRUMENT IS DESIGNED NOT THE BREAK AT ALL, NEITHER AT THE END NOR AT THE TIP OF THE SHAFT. SINCE THIS EVALUATION INDICATED NO MATERIAL DEFECT, NO DEFECT IN DESIGN OR ANY DEFECT IN MANUFACTURING, WE FEEL THAT NO CORRECTIVE ACTION IS TO BE TAKEN.