BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5MM DRILL BIT/CONICAL W/STOP

    MDR report key: 3183149 · Received June 21, 2013

    Report

    Report Number
    8030965-2013-03289
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    March 12, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. THE ADDITIONAL EVALUATION REVEALED THAT THE COMPLETE SPIRAL DRILL HAS CHANGED COLOR. DUE TO A SINGLE REWORK ON INDIVIDUAL DRILLS FROM THE PRODUCED LOT, AN ADJUSTMENT TO THE PRODUCTION PROCESS SURFACE FINISH WAS REQUIRED. THE REWORK IS NECESSARY FOR THE OXIDATION AFTER STERILIZATION OF THE DRILL. SINCE THE REWORK DID NOT OCCUR FOR THE ENTIRE LOT ((B)(4)), BUT RATHER ONLY FOR A SMALL NUMBER, NO BLOCKING OF THE ENTIRE LOT WAS TRIGGERED. HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. AN INTERNAL CORRECTIVE ACTION DETERMINATION HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SPIRAL DRILL BIT HEAD HAS BROWN SPOTS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282706 6.5MM DRILL BIT/CONICAL W/STOP HTW SYNTHES GMBH 2658905

    Patients

    Seq Age Sex Outcome Treatment
    1