MalfunctionEMH

3T

Received Jul 26, 2016 · Event occurred Jul 1, 2016

Report 5821721 · MDR key 5821721

Device

Generic name

Forceps, Rongeur, Surgical

Manufacturer

Premier Dental Products Co.

Model number

Catalog number

1003062

Product problems

Break

Patient

Not reported

No Known Impact Or Consequence To Patient
No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

DURING A DENTAL PROCEDURE AN INSTRUMENT BROKE IN THE PATIENT'S MOUTH DURING USE. THE PATIENT HAD A THROAT PACK IN DURING PROCEDURE. SURGEON WAS ABLE TO RETRIEVE THE MISSING PIECE AND BOTH PIECES OF THE INSTRUMENT WERE REMOVED FROM THE FIELD AND SAVED.