DRILL BIT 1.1 L45/33 2FLUTE
Received Oct 19, 2012 · Event occurred Sep 20, 2012
Report 2520274-2012-02353 · MDR key 2826673
Device
Generic name
Drill Bit
Catalog number
513.030
Lot number
424267
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING A PROCEDURE, THE DRILL BIT BROKE. ALL FRAGMENTS WERE RETRIEVED, NOTHING WAS LEFT IN THE PATIENT. PROCEDURE WAS COMPLETED.
Additional Manufacturer Narrative
THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE MEASURABLE DIMENSIONS WERE CHECKED AS FAR AS POSSIBLE AND WERE FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE EXAMINATION OF THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD. THE FRACTURE FACE IS HOMOGENEOUS WHICH INDICATES MATERIAL CONFORMITY. THE CUTTING EDGES ABOVE THE FRACTURE ARE BLUNT. WE SUPPOSE THAT AN EXCESSIVE METALLIC CONTACT IN COMBINATION WITH TOO MUCH LATERAL STRESS CAUSED THIS BREAKAGE. NO PRODUCT FAULT COULD BE DETECTED.
Additional Manufacturer Narrative
THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.