BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.0MM/10.0MM STEPPED DRILL BITCANNULATED/LARGE QC/435MM

    MDR report key: 3133156 · Received May 29, 2013

    Report

    Report Number
    1719045-2013-01478
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED REVEALED THERE WERE NO MRRS, NCRS, OR COMPLAINT RELATED ISSUES WITH THIS COMPLAINT. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. REVIEW OF THE SYNTHES DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RETURNED DEVICE, 6.0MM/10.0MM STEPPED DRILL BITCANNULATED/LARGE QC/435MM PART#357. (B)(4) (LOT#US93044) WAS MANUFACTURED IN AUGUST 2008 AND IS OVER 4 YEARS OLD. THE DRILL BIT IS CONFIRMED FRACTURED ON THE DISTAL END, WITH THE FRACTURE APPROXIMATELY 15MM FROM THE DISTAL TIP. THESE DRILL BITS ARE RECOMMENDED TO BE SINGLE USE, BUT IT IS UP TO THE HOSPITAL¿S DISCRETION IF THEY WOULD LIKE TO USE IT MORE THAN ONCE. THE INSERT GP0680 PACKAGED WITH THE DEVICE REVIEWS THE INSPECTION STEPS TO ENSURE THERE ARE NO DULL OR DAMAGED EDGES, IF THERE ARE IT SHOULD BE REPLACED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THEREFORE, THIS COMPLAINT IS INVALID FROM A DESIGN PERSPECTIVE.

    Description of Event or Problem · 1

    DURING A TFN PROCEDURE ON (B)(6) 2013, WHILE DRILLING FOR THE HELICAL BLADE, REPORTEDLY THE TIP OF THE STEPPED DRILL BIT BROKE OFF INSIDE THE NAIL. THE SURGEON BACKED OUT THE NAIL TO RETRIEVE THE DRILL BIT AND RE-INSERTED THE NAIL. THE SURGEON OPENED ANOTHER TFN SET AND USED ANOTHER STERILE DRILL BIT. THE HELICAL BLADE WAS THEN INSERTED WITH NO FURTHER PROBLEM. REPORTEDLY THE PATIENT IS RECOVERING WELL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234736 6.0MM/10.0MM STEPPED DRILL BITCANNULATED/LARGE QC/435MM HTO SYNTHES MONUMENT US93044

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR