BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.0MM/10.0MM STEPPED DRILL BIT

    MDR report key: 3003419 · Received February 28, 2013

    Report

    Report Number
    1719045-2013-10248
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    May 27, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. MANUFACTURING EVALUATION REPORTS THAT THE SAMPLE WAS RECEIVED WITH THE TIP OF THE DRILL BROKEN AND EXHIBITS DAMAGE. SLIGHT DAMAGED NOTED ON THE REMAINING CUTTING EDGES ALONG THE AXIS OF THE LARGE FLUTE AREA. SCUFF MARKS WERE ALSO LOCATED ON THE SHAFT AND THE TANG. PARTS WERE MADE TO ACCORDING TO PRODUCT DRAWINGS AND PRINT SPECIFICATIONS WERE MET PRIOR TO RELEASE. THE CAUSE OF THE BROKEN TIP IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING PERSPECTIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE 6.0/10.0MM STEPPED DRILL BIT BROKE OFF DURING A PROCEDURE. TIP WAS RETRIEVED AND PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87000 6.0MM/10.0MM STEPPED DRILL BIT HTO SYNTHES (USA) UP52335

    Patients

    Seq Age Sex Outcome Treatment
    1