BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT FOR 5.0MM RECON SCREWS/LARGE QC

    MDR report key: 3062466 · Received April 16, 2013

    Report

    Report Number
    1719045-2013-10698
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    February 16, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSPECTION OF AN EVALUATION SET, THE DRILL STOP WAS FOUND TO SLIP ALONG THE REAMER. THE PRODUCT WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. THIS REPORT IS FOR FILE (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163958 DRILL BIT FOR 5.0MM RECON SCREWS/LARGE QC HTW SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1