DRILL BIT Ø1.1 L45/33 2FLUTE
Received Nov 21, 2012 · Event occurred Oct 20, 2012
Report 2520274-2012-03303 · MDR key 2841828
Device
Product problems
- Break
Patient
18 YR
- Bone Fracture(s)
Narrative
Additional Manufacturer Narrative
DEVICE WAS USED FOR TREATMENT. INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES THE DIMENSIONS OF THE BROKEN DRILL BIT 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. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH LEADS TO THIS OCCURRENCE. IT IS POSSIBLE THAT TOO MUCH MECHANICAL FORCE WAS APPLIED DURING THE SURGERY (TOO HIGH DRILL SPEED, HARD BONE OR POSSIBLE MOVEMENT IN A SLANTING POSITION). NO PRODUCT FAULT COULD BE DETECTED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.
Description of Event or Problem
DEVICE REPORT FROM (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT PRESENTED WITH FRACTURE OF FIRST METACARPAL ON THE RIGHT HAND FOLLOWING A TRAFFIC ACCIDENT. THE SURGEON WAS DRILLING THE CORTICAL BONE AND THE DRILL BIT DID NOT ADVANCE. AT THE EXTRACTION POINT, IT WAS NOTED THE DRILL BIT WAS BROKEN.