IVORY CLAMP
Received Jun 20, 2012 · Event occurred May 23, 2012
Report 1925223-2012-00045 · MDR key 2629817
Device
Product problems
- Break
- Material Fragmentation
Patient
60 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
ON (B)(6) 2012, HENRY SCHEIN REP SENT (B)(4). THE DESCRIPTION ON THE FORM WAS, "CLAMP BROKE IN PT'S MOUTH WITH NO INJURY." ON (B)(4) 2012, I SPOKE TO THE ASSISTANT. I ASKED WHEN THIS OCCURRED. SHE SAID IT WAS ON FRIDAY ((B)(6) 2012). SHE SAID THE PT WAS (B)(6) MALE. THEY WERE REMOVING THE CLAMP FROM A LOWER MOLAR, SHE DID NOT REMEMBER WHICH ONE, AND IT BROKE. SHE SAID THAT THE RUBBER DAM WAS IN PLACE AND THE CLAMP PIECES FELL TO THE FLOOR. I ASKED HER IF SHE KNEW HOW MANY USES WERE ON THE CLAMP. SHE SAID SHE WAS NOT SURE, BUT THAT THE CLAMP WAS FAIRLY NEW. I ASKED IF ANYONE WAS INJURED. SHE SAID THAT NO ONE WAS INJURED.
Additional Manufacturer Narrative
DUE TO THE CLAMP BREAKAGE ALLEGEDLY OCCURRING ON FAIRLY NEW THE CLAMP THE MALFUNCTION WILL BE REPORTED TO MAINTAIN COMPLIANCE WITH 21 CFR 803 AND OUT OF AN ABUNDANCE OF CAUTION. CONCLUSION: DEVICE BREAKAGE IS ADDRESSED IN THE DIRECTIONS FOR USE. THE DIRECTIONS STATE, "CAUTION: MODIFICATION, OVEREXTENDING, BENDING OR EXTENDED USE OF THE CLAMP MAY CAUSE BREAKAGE." THE DENTIST HAS STATED THAT NO ONE WAS INJURED DURING THE INCIDENCES.