inforMED
OtherEKT

HU-FRIEDY SUB-0 VISION CURETTE #6

Received Dec 7, 2011 · Event occurred Oct 17, 2011

Report 1416605-2011-00004 · MDR key 2379116

Device

Generic name

Sgcsub - 06

Model number

SGCSUB-06

Catalog number

SGCSUB-06

Lot number

0711

Product problems

  • Break

Patient

58 YR

  • Tissue Damage

Narrative

Additional Manufacturer Narrative

THICKNESS AT THE HEEL OF THE UNBROKEN WORKING END MEASURES 0.0185" AND THE THICKNESS IN THE MIDDLE OF THE BLADE MEASURES 0.0215". BOTH MEASUREMENTS ARE WITHIN THE SPECIFICATION OF 0.020" +/- 0.002." BASED ON VISUAL/DIMENSIONAL ANALYSIS, THE REASON FOR THE BREAKAGE OF THE INSTRUMENT CANNOT BE DETERMINED. ADD'L FUNCTIONAL TESTING WILL BE CONDUCTED.

Description of Event or Problem

A PERIODONTIST WAS PERFORMING SCALING AND ROOT PLANNING ON PT'S SUPPER LEFT SIDE BETWEEN 12 & 13 WHEN THE CURETTE BROKE OFF AND BECAME EMBEDDED IN THE PT'S TISSUE. THE DOCTOR CONFIRMED WITH AN X-RAY THAT THE TIP WAS EMBEDDED AND THEN PROCEEDED TO PERFORM A PERIODONTAL FLAP SURGERY FOR REMOVAL THE TIP AND DEBRIDEMENT OF THE AREA.

Remedial action

  • Other