BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE HOLDING DRILL GUIDE - SINGLE BARREL/FIXED ANGLE

    MDR report key: 2925555 · Received January 22, 2013

    Report

    Report Number
    8030965-2013-00221
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 31, 2012
    Report Date
    December 31, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A PRODUCT DEVELOPMENT EVALUATION WAS CONDUCTED AND THE REPORT INDICATES THE DRILL GUIDE WAS RECEIVED WITH A BROKEN HANDLE AND OXIDATION ON THE ETCHING. THERE ARE ALSO MINOR SCRATCHES ON THE SURFACE. THE HANDLE IS FRACTURED ABOVE THE PIN WHICH RETAINS THE RADEL HANDLE ON THE MAIN BODY OF THE INSTRUMENT. THE FAILURE COULD HAVE OCCURRED FROM EITHER THE INSTRUMENT BEING DROPPED ON THE FLOOR OR COMPRESSED BEYOND THE INTENDED FUNCTION FOR PLATE RETAINMENT. AS THE FRACTURED HANDLE OCCURRED OUTSIDE OF THE SURGICAL FIELD AND NOT AT THE BACK TABLE IT IS NOT CLEAR HOW IT BROKE. THE ENGINEER LOCATED THE RISK ANALYSIS FOR THIS PART AND THE RISK OF THE HANDLE BREAKING IS NOT ADDRESSED.

    Description of Event or Problem · 1

    PRIOR TO AN ACDF AT C5-C6, THE VECTRA DRILL GUIDE BROKE. THIS HAPPENED IN THE OPERATING ROOM, BUT OUTSIDE THE SURGICAL FIELD, NOT AT THE BACK TABLE. THERE WERE NO FRAGMENTS TO RETRIEVE AND THERE WAS NO HARM TO THE PATIENT. ANOTHER DRILL GUIDE WAS AVAILABLE TO USE. THE SURGEON COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEM AND THE PATIENT IS REPORTEDLY RECOVERING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29442 PLATE HOLDING DRILL GUIDE - SINGLE BARREL/FIXED ANGLE PLATE HOLDING DRILL GUIDE FZX SYNTHES GMBH 1597473

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR