BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORACLE SLIDE HAMMER

    MDR report key: 3231263 · Received July 17, 2013

    Report

    Report Number
    1719045-2013-01816
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    April 11, 2013
    Report Date
    May 17, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AVAILGN-NEMCOMED MANUFACTURED THE ORACLE SLAP HAMMER PN 03.809.972, LOT 6678491. DUE TO AN UNKNOWN CAUSE, THE SLIDE IS STUCK TO THE SHAFT. THE MATERIAL OF THE HEAD, SHAFT AND SLIDE WAS DETERMINED TO BE WITHIN SPECIFICATION. THE HARDNESS OF THE SHAFT WAS ALSO WITHIN SPECIFICATION. THE INSTRUMENT CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING. THE DIAMETER OF THE SHAFT WAS CONFIRMED TO BE WITHIN SPECIFICATION. BASED ON THE UNKNOWN ROOT CAUSE, AND THE EVALUATION PERFORMED BY SYNTHES, THIS COMPLAINT IS DEEMED INVALID FROM A MANUFACTURING POSITION. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. AVALIGN TECHNOLOGIES MANUFACTURED THE ORACLE SLAP HAMMER, P/N 03.809.972, AND LOT NUMBER 6638494. THE SUPPLIERS CERTIFICATE OF COMPLIANCE (DATED JUNE 3, 2011) INDICATES THE PARTS WERE MANUFACTURED TO P/N 03.809.972, REVISION B AND MET THE REQUIRED SPECIFICATIONS. THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES, INCOMING FINAL INSPECTION SHEET NUMBER NS027776, REVISION B (COMPLETED JUNE 7, 2011). THERE WERE NO MRRS, NCRS, OR COMPLAINT RELATED ISSUES WITH THIS COMPLAINT. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2013, THE HANDLE OF THE HAMMER WAS STUCK WHILE HAMMERING. THE CAUSE OF THE PROBLEM IS UNCLEAR. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332251 ORACLE SLIDE HAMMER FZY SYNTHES MONUMENT 6638494

    Patients

    Seq Age Sex Outcome Treatment
    1