BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR F/BROKEN SCREW

    MDR report key: 3240684 · Received July 22, 2013

    Report

    Report Number
    1719045-2013-01815
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    June 24, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 RECORDS (DHR) HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE SUPPLIER¿S CERTIFICATE OF COMPLIANCE (DATED APRIL 21, 2011) INDICATES THE PARTS WERE MANUFACTURED TO P/N 03.505.222, REVISION ¿D¿ AND MET THE REQUIRED SPECIFICATIONS. THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES, INCOMING FINAL INSPECTION SHEET NUMBER (B)(4) REVISION ¿E¿ (DATED APRIL 29, 2011). THERE WERE NO MRR¿S, NCR¿S, OR COMPLAINT RELATED ISSUES WITH THIS COMPLAINT. THE MATERIAL OF THE EXTRACTOR WAS CONFIRMED TO BE CORRECT. THE PART CONFORMED TO ALL DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING. THE DIAMETER OF THE PART WAS CONFIRMED TO BE WITHIN SPECIFICATIONS. PER THE SUPPLIER¿S CERTIFICATE OF COMPLIANCE, THE HEAT TREAT VALUES MEET REQUIRED SPECIFICATIONS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: DURING A PROCEDURE ON AN UNKNOWN DATE, THE DRILL BROKE WHEN THE SURGEON TRIED TO REMOVE A SCREW OUT OF A PATIENT. IT WAS ALSO REPORTED, A SMALL PART OF THE DRILL THAT BROKE COULD NOT BE FOUND. NO FURTHER INFORMATION WAS PROVIDED. THIS IS 1 OF 1 DEVICE FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341021 EXTRACTOR F/BROKEN SCREW HWB SYNTHES MONUMENT 6576882

    Patients

    Seq Age Sex Outcome Treatment
    1