BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø2/1.15 CANN L150/48 3FLUTE

    MDR report key: 3062336 · Received April 16, 2013

    Report

    Report Number
    8030965-2013-01707
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 21, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE PRESENT DRILL BIT WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED; NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. THE EXACT CAUSE OF THIS OCCURRENCE CAN NOT BE DEFINED. IT IS VISIBLE THAT THE CUTTING EDGES ABOVE THE FRACTURE ZONE ARE DAMAGED. THIS IS AN INDICATION THAT AN EXCESSIVE METALLIC CONTACT DURING THE REMOVAL, PAR EXAMPLE WITH THE DRILL SLEEVE, COULD HAVE CAUSED THIS BREAKAGE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: SURGEON WAS PERFORMING A TRAUMA PROCEDURE TO FIX A RADIAL HEAD AND CAPITELLUM ON (B)(6) 2013. FOLLOWING THE INSERTION OF THE FIRST GUIDE WIRE, AS SURGEON WAS REMOVING THE DRILL BIT FROM THE PATIENT, THE END FLUTES OF THE DRILL BIT SHATTERED INTO THREE PIECES. THEY SUBSEQUENTLY HAD TO BE REMOVED ONE BY ONE FROM THE WOUND AND A SECOND DRILL BIT WAS USED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162547 DRILL BIT Ø2/1.15 CANN L150/48 3FLUTE HWE SYNTHES GMBH F-12542

    Patients

    Seq Age Sex Outcome Treatment
    1