DRILL BIT 1.5 L45/33 2FLUTE
Received Oct 24, 2012 · Event occurred Sep 12, 2012
Report 2520274-2012-02545 · MDR key 2815497
Device
Product problems
- Break
- Fracture
Patient
Not reported
- Bone Fracture(s)
Narrative
Description of Event or Problem
A PIECE OF ONE OF THE DRILL BITS WAS LEFT WITHIN THE PATIENT; HOWEVER, THE PATIENT IS REPORTEDLY IN PERFECT CONDITION AFTER SURGERY.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION RECEIVED. NOT PREVIOUSLY REPORTED. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE MEASURABLE DIMENSIONS OF THE BROKEN DRILL BITS WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE EXAMINATION OF THE RAW MATERIAL TESTING CERTIFICATES AND 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. AN EXACT CAUSE FOR THIS OCCURRENCE COULD NOT BE DETERMINED. IT CAN ONLY BE ASSUMED THAT TOO MUCH MECHANICAL FORCE HAD BEEN APPLIED DURING THE SURGERY, I.E. TOO HIGH DRILL SPEED, HARD BONE OR POSSIBLE MOVEMENT IN A SLANTING POSITION. THESE ARE VERY DELICATE DRILL BITS WHICH REQUIRE EXTRA CAUTION DURING USE. NO PRODUCT FAULT COULD BE DETECTED. DATE OF MANUFACTURE DETERMINED FROM LOT NUMBER OF THE DEVICE.
Additional Manufacturer Narrative
THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS.(B)(4): PLACEHOLDER.
Description of Event or Problem
A DEVICE REPORT FROM SYNTHES (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING A LEFT HUMEUS FRACTURE PROCEDURE, THE DRILL BITS FRACTURED DURING THE PERFORATION PROCESS WITH THE AIR PEN DRIVE. THERE WAS NO ISSUE RECOGNIZED WITH THE AIR PEN DRIVE. SURGEON USED KIRSCHNER WIRES INSTEAD OF PLATE AND SCREWS. THE LOCATION OF THE THREE BROKEN DRILL BIT TIPS IS UNKNOWN. IT WAS CONFIRMED THAT THE FOURTH BROKEN DRILL BIT TIP WAS NOT LEFT IN THE PATIENT. THIS IS NUMBER 3 OF 4 REPORTS FOR THE SAME EVENT.
Additional Manufacturer Narrative
THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.