A DEALER REP. REPORTED THAT HE PICKED UP A BROKEN CLAMP FROM A DENTAL OFFICE. HE HAD NO FURTHER INFORMATION OTHER THAN THE DOCTOR WAS UNHAPPY THIS BROKE. (B)(6) 2014, SPOKE TO OFFICE STAFF MEMBER. SHE SAID THAT THEY HAD THE CLAMP ABOUT 6 MONTHS. SHE SAID THEY ONLY USE IT ABOUT ONCE A WEEK SO IT WAS PROBABLY USED ABOUT 24 TIMES. SHE SAID THAT THE CLAMP BROKE WHILE IT WAS BEING PLACED ON THE BICUSPID. SHE DID NOT REMEMBER WHAT DAY OR THE PATIENT. SHE SAID THAT THERE WERE NO INJURIES; HOWEVER, IT WAS VERY UPSETTING WHEN IT BROKE. SHE SAID THAT IT BROKE ALONG THE BOW AND THEY WERE ABLE TO RETRIEVE BOTH PIECES. SHE SAID THAT THEY AUTOCLAVE IN A M11 MACHINE ON BAGGED SETTING. SHE MENTIONED THAT THEY HAD SWITCHED DUE TO A NUMBER OF (B)(4) CLAMPS BREAKING ALONG THE WING.
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Patient 1
ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. THE DEVICE WAS FOUND TO HAVE RECEIVED MULTIPLE DAMAGE POINTS AND AN EXCESSIVE DAMAGE AREA ON THE TOP SIDE OF THE JAW AND BOW, BY A DENTAL GRINDING TOOL. DEVICE BREAKAGE IS ADDRESSED IN THE DIRECTIONS, "DO NOT PLACE CLAMP IN MOUTH UNTIL THE RUBBER DAM HAS BEEN PROPERLY PLACED. CLAMP COULD BECOME A CHOKING OR SAFETY HAZARD IF DROPPED OR BROKEN IN THE MOUTH WITHOUT PROPER USE OF THE RUBBER DAM AT ALL TIMES." THE DIRECTIONS WARN, "CAUTION: MODIFICATION, OVER-EXTENDING, BENDING, OR USE EXCEEDING ONE YEAR MAY CAUSE BREAKAGE." THE DENTIST SAID THAT NO ONE WAS INJURED DURING THE INCIDENCE.