REPORTED BY (B)(6) OF (B)(6): IVORY CLAMP SS 12A REG MOLAR SNAPPED AT (B)(6) DENTAL CLINIC. CALLED AND SPOKE WITH (B)(6), WHO STATED BOTH CLAMPS WERE NEW, PATIENTS WERE INVOLVED (SEE ALSO (B)(4)), BUT NO ONE WAS INJURED. (B)(6) STATED THE OFFICE USES A VARIETY OF RUBBER DAM FORCEPS: (B)(4). ADVISED (B)(6) THAT IVORY BRAND FORCEPS ARE MANUFACTURED TO SPECIFICATIONS OF THE CLAMP EXTENSION. OTHER FORCEPS MAY ALLOW THE PRONGS TO OPEN TOO FAR AND HYPER EXTEND THE WINGS OF THE CLAMP, POTENTIALLY LEADING TO FRACTURE. THIS CLAMP BREAKAGE OCCURRED IN (B)(6).
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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. DISTORTING THE CLAMP DURING USAGE CAUSING BREAKAGE OF THE CLAMP. DEVICE BREAKAGE IS ADDRESSED IN THE DIRECTIONS FOR USE. THE DIRECTIONS STATE, "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 FOR USE WARNS, "CAUTION: MODIFICATION, OVER-EXTENDING, BENDING, OR USE EXCEEDING ONE YEAR MAY CAUSE BREAKAGE." THE USER TWISTED AND BENT THE CLAMP IN A MANNER THAT IS CONTRAINDICATED. THE DIRECTIONS CONTAIN ADEQUATE WARNING AND INSTRUCTIONS. OVER-EXTENSION OF THE CLAMP CAUSED PERMANENT DEFORMATION TO THE CLAMP AND SUBSEQUENTLY BREAKAGE OF THE CLAMP.