MACHTOU PLUGGER 001/002
Received Dec 6, 2018
Report 9611053-2018-00221 · MDR key 8139188
Device
Generic name
Plugger, Root Canal, Endodontic
Manufacturer
Dentsply Vdw GmbhModel number
NACatalog number
V041063001002
Lot number
UNK
Product problems
- Break
- Break
- Material Separation
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE ACTIVE PART #1 OF THE RETURNED PLUGGER IS ACTUALLY BROKEN ON THE FIRST DEPTH RING. NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERN. ACTIVE PART #2 IS NOT DAMAGED. THE BATCH NUMBER IS UNKNOWN, DHR CANNOT BE REVIEWED. ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. FOR INFORMATION, MSA RECOMMENDS TO DO NOT APPLY A TOO HIGH BENDING FORCE DURING THE USE OF THIS INSTRUMENT.
Additional Manufacturer Narrative
WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803. PLEASE NOTE THAT WHILE THIS PRODUCT IS NOT SOLD IN THE US, IT IS CONSIDERED SIMILAR TO PRODUCTS THAT ARE MARKETED IN THE US BY DENTSPLY (B)(4). THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.
Description of Event or Problem
IN THIS EVENT, IT WAS REPORTED THAT A MACHTOU PLUGGER SEPARATED. THE BROKEN PIECE HAS BEEN RETRIEVED AND NO INJURY RESULTED.