Additional Manufacturer Narrative · 1
AS PER INFO RECEIVED FROM THE DISTRIBUTOR THE TIP OF BONE HOOK BROKE OFF DURING A PROCEDURE. WE HAVE NOT REC'D ANY INFO AS TO WHETHER THE PT INCURRED ANY INJURY. [SEE SCANNED PAGE]. AS REQUESTED, THE INSTURMENT WAS THOROUGHLY CHECKED BY SENIOR SURGICAL INSTRUMENT ENGINEER AND GENERAL MGR: WITH LOT #C5, 50 INSTRUMENTS HAVE BEEN MANUFACTURED IN MAI 2006, AND DELIVERED TO THE DISTRIBUTOR ON MAY 12TH, 2006. SINCE OCTOBER 2005, WHEN WE STARTED DELIVERY OF THIS TYPE OF ARTICLE (ARTICLE NOS. 240-195, 240-196, 240-197), WE HAVE SHIPPED A LOT OF QUANTITY OF THESE ARTICLES TO THE DISTRIBUTOR. WE HAVE REC'D FOUR OTHER COMPLAINTS IN 2006 WITH REGARD TO THIS PRODUCT FAMILY, HOWEVER, ANOTHER TYPE OF COMPLAINT, SINCE THE INSTRUMENTS INVOLVED WITH THESE FOUR COMPLAINTS DID NOT BREAK, BUT WERE BENT OR STRAIGHTENED OUT. [SEE SCANNED TABLE]. THE PRODUCT DOCUMENTS OF THIS LOT PROVE THAT THE RIGHT MATERIALS / COMPONENTS WERE USED AND THAT THE INSTRUMENT WAS MANUFACTURED IN ACCORDANCE WITH THE PRODUCTION SPECIFICATIONS. WE PERFORMED A HARDNESS TEST, WHICH RESULTED IN 48 HRC THAT IS STILL WITHIN THE GIVEN RANGE OF TOLERANCE. CONCLUSION: BASED ON OUR LONGTERM EXPERIENCE AS QUALIFIED INSTRUMENT MFR, WE ASSUME THAT THE INSTRUMENT WAS STRESSED IN EXCESS OF ITS DESIGN AND, THUS, ITS INTENDED USE, WHAT FINALLY COULD HAVE CAUSED THE BREAK.