BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø2/1.15 CANN L150/48 3FLUTE

    MDR report key: 3183597 · Received June 22, 2013

    Report

    Report Number
    8030965-2013-03150
    Event Type
    Malfunction
    Date Received
    June 22, 2013
    Date of Event
    August 1, 2012
    Report Date
    August 21, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE ADDITIONAL EVALUATION REVEALED THAT TIP OF THE DRILL BIT IS DAMAGED. THE BROKEN FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. THE DRILL BIT IS BROKEN DUE TO MECHANICAL OVERLOADING DURING USE. WE STRONGLY HAVE TO ASSUME THAT THE TIP OF THE DRILL BITS CAME IN STRONG CONTACT WITH THE K WIRE AND BLOCKED WHAT LEAD TO BREAKAGE FINALLY. NO PRODUCT FAULT COULD BE DETECTED. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES HSZ, GFA, AND GFF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE DRILL BIT WAS DAMAGED. WHEN INSERTING A HCS, THE DOCTOR DRILLED THE BONE OF THE YOUNG PATIENT, AND AFTER HE INSERTED A GUIDE. THE BONE WAS DRILLED THROUGH TO THE OTHER SIDE TO HANG THE SCREW, WHEN IT SOUNDED LIKE THE BONE BROKE. THIS IS BELIEVED IS WHEN THE DRILL MIGHT HAVE BROKEN. LATER AN IMAGE SHOWED THAT AFTER INSERTING THE SCREW INTO THE BONE, THERE WAS FOREIGN SUBSTANCE. THE DOCTOR NOTICED THAT THE TIP OF THE DRILL WAS DAMAGED. FORTUNATELY THE DOCTOR REMOVED IT AFTER THE SCREW WAS PULLED OUT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284316 DRILL BIT Ø2/1.15 CANN L150/48 3FLUTE HWE SYNTHES GMBH 421446

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR