HYGENIC

Description of Event or Problem

DENTAL CLAMP BROKE DURING SET UP.

Additional Manufacturer Narrative

INVESTIGATION RESULTS: NO PRODUCT WAS RETURNED. NO DATE CODE MENTIONED. BATCH NUMBER INDICATES 2 YEARS OLD. WHY DID THE CLAMP BREAK? THE CLAMP BROKE DUE TO THE INABILITY OF THE MATERIAL TO WITHSTAND THE STRESSES BEING APPLIED. WHY? 1) THE CLAMP IS OLD AND BROKE DUE TO THE EXPECTED LIFE OF USAGE. 2) THE CUSTOMER HAS EXPOSED THE CLAMP TO CHEMICALS KNOWN TO CAUSE STRESS CRACK CORROSION OR HAS NOT RINSED IT OFF BEFORE AUTOCLAVING. 3) CUSTOMER IS NOT AWARE THAT OVEREXTENDING CLAMPS IS DETRIMENTAL TO THE "SPRING" MATERIAL OF THE CLAMP AND DECREASES THE LIFE EXPECTANCY. 4) NO OTHER ISSUES HAVE COME UP FOR THIS BATCH OF CLAMPS. 5) CUSTOMER IS SATISFIED WITH THE PRODUCT CREDIT/REPLACEMENT AND HAS NOT REQUESTED ADDITIONAL INFORMATION. ATTACHED PHOTOS EXHIBIT DARK DISCOLORATION ON THE ENTIRE SURFACE OF THE CLAMP INDICATING POSSIBLE CAUSTIC/ACIDIC CHEMICAL USAGE. AT THE BREAK, THE BLACK DISCOLORATION INDICATES THE BREAKING WAS CAUSED BY CHEMICAL CORROSION. CLAMP WAS 2 YEARS OLD AND PROBABLY AT THE END OF ITS LIFE EXPECTANCY. ABLE (3 OCCURENCES FROM (B)(6) 2017 TO (B)(6) 2018) CAPA REQUIRED: NO CAPA REQUIRED.