BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM DRILL BIT/QC/GOLD/110MM

    MDR report key: 3607155 · Received February 4, 2014

    Report

    Report Number
    1719045-2014-00076
    Event Type
    Malfunction
    Date Received
    February 4, 2014
    Date of Event
    January 14, 2014
    Report Date
    January 14, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTW
    PMA / PMN Number
    K962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT AND NOT DIAGNOSIS. THE PRODUCT DEVELOPMENT EVALUATION STATED: THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION; THUS, THIS COMPLAINT IS INVALID FROM A DESIGN PERSPECTIVE. MOREOVER, THE RETURNED DRILL BIT WAS RETURNED WITH THE DISTAL TIP FRACTURE MID FLUTE, WHEREIN, THE MOST LIKELY CAUSE FOR THIS COMPLAINT WAS TOO MUCH OFF-AXIS FORCES BEING APPLIED TO THE DRILL LEADING TO THE DRILL BREAKING; PER THE COMPLAINT DESCRIPTION.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM.(B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/ EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING EVALUATION REPORT STATED: ORCHID UNIQUE MANUFACTURED THE 2.5MM DRILL BIT WITH QUICK COUPLING, GOLD, 110MM, P/N 310.25, AND LOT NUMBER U172601. THE COMPLAINT CONDITION (DRILL BIT BROKE) IS DUE TO AN UNKNOWN CAUSE. THE LOT INITIALLY CONFORMED TO ALL REQUIREMENTS PER THE CERTIFICATE OF CONFORMANCE AND WAS INSPECTED / CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER NS061004, REVISION ¿A¿. BASED ON THE EVALUATION PERFORMED AND THE UNKNOWN CAUSE, THIS COMPLAINT IS DEEMED INVALID FROM A MANUFACTURING POSITION. PROCODE: HSZ.

    Description of Event or Problem · 1

    THE RESIDENT WAS DRILLING FOR A 3.5MM CORTEX SCREW WITH A 310.25 DRILL AND PLACED TOO MUCH PRESSURE ON THE DRILL WHILE DRILLING WITH THE GUIDE AND THE 2.5MM DRILL BIT, PART NUMBER 310.25, BROKE. THE ATTENDING PHYSICIAN WARNED THE RESIDENT THAT THE DRILL BIT WAS GOING TO BREAK IF HE CONTINUED IN THAT MANNER, HE CONTINUED, AND THE DRILL BIT BROKE. THE BROKEN DRILL BIT WAS EASILY REMOVED AND WILL BE RETURNED FOR EVALUATION. FRACTURE REDUCED PROCEDURE COMPLETED SUCCESSFULLY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72588 2.5MM DRILL BIT/QC/GOLD/110MM HTW SYNTHES MONUMENT U172601

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR