GT FIBER POST 1MM
Received Apr 11, 2024
Report 2320721-2024-00021 · MDR key 19091500
Device
Generic name
Post, Root Canal
Manufacturer
Tulsa Dental Products LlcCatalog number
GTPOSTF1
Lot number
0000392513
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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. INVESTIGATION RESULTS: RETURNED 1X GTPOSTF1 DRILL. CHECKED UNDER MICROSCOPE AND FOUND NO MANUFACTURING MARKS OR DEFECTS. SEE ATTACHED PHOTO, BREAK OCCURRED BETWEEN THE HANDLE AND THE 1ST CALIBRATION LINE. UNIT SETTING AND NUMBER OF USES IS UNKNOWN. NO OTHER COMPLAINTS FOR THIS LOT NUMBER. NO UNOPENED PRODUCT WAS RETURNED THEREFORE NO FURTHER TESTING CAN BE PERFORMED AND ROOT CAUSE IS UNKNOWN. DHR: NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW. A QUERY INDICATES NO ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED FOR THIS LOT NUMBER.
Description of Event or Problem
IN THIS EVENT IT IS REPORTED THAT GT FIBER POST 1MM - POST DRILL BROKE DURING USE. THE BROKEN PIECES WERE RETRIEVED AND NO INJURY RESULTED.