BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    14.5MM OUTER PROTECTION SLEEVEFOR SUPRAPATELLAR - STERILE

    MDR report key: 3344015 · Received September 12, 2013

    Report

    Report Number
    1719045-2013-01948
    Event Type
    Malfunction
    Date Received
    September 12, 2013
    Date of Event
    August 18, 2013
    Report Date
    August 18, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDS
    PMA / PMN Number
    K111667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. C & J INDUSTRIES MANUFACTURED THE 14.5MM OUTER PROTECTION SLEEVE FOR SUPRAPATELLAR - STERILE, P/N 03.010.438S, AND LOT NUMBER 7069802. THE SUPPLIERS CERTIFICATE OF COMPLIANCE (DATED DECEMBER 6, 2012) INDICATES THE PARTS WERE MANUFACTURED TO P/N 03.010.438S, REVISION C AND MET THE REQUIRED SPECIFICATIONS. THE LOT WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER NS039697, REVISION C (DATED JANUARY 9, 2013). NCR 1072289 (WRITTEN JANUARY 9, 2013) WAS FOR THE INCORRECT PART NUMBER DOCUMENTED ON THE CERTIFICATE OF CONFORMANCE. THE CERT WAS CHANGED AND RETURNED TO SYNTHES, AND THE NCR WAS CLOSED FEBRUARY 25, 2013. HOWEVER, IT HAS SINCE BEEN DETERMINED THAT THE INCORRECT PARTS WERE SHIPPED TO SYNTHES. THE SUPPLIER PROVIDED 03.010.437S 12.0 MM OUTER PROTECTION SLEEVE FOR SUPRAPATELLAR - STERILE IN LIEU OF 03.010.438S. STOCK HOLD/STOCK EVAL 1523 HAS BEEN OPENED TO ADDRESS THIS ISSUE. THEREFORE, THIS IS A VALID COMPLAINT FROM A MANUFACTURING POSITION. THIS WAS NOT CAUGHT AT INCOMING INSPECTION DUE TO THE PART BEING STERILE AND NEEDING TO PERFORM DESTRUCTIVE TESTING IN ORDER TO INSPECT THIS FEATURE. PLACEHOLDER.

    Description of Event or Problem · 1

    DURING A TIBIA NAIL IMPLANT PROCEDURE IT WAS DISCOVERED THAT THE PACKAGING AND LABELING WAS INCORRECT FOR AN ORDERED INSTRUMENT. THE PACKAGED INSTRUMENT DID NOT FIT. THE SURGEON REQUESTED THE LARGER OF 2 SLEEVES. THE SC REPORTED THAT THE LABELING IS FOR 14.5/3.2MM FOR SUPRAPATELLAR, STERILE PART NUMBER 03.010.438 S, WHICH WAS REQUESTED. THE INSTRUMENT IN THE PACKAGE WAS PART NUMBER 03.010.437 S 12.0 MM OUTER PROTECTION SLEEVE, FOR SUPRAPATELLAR, STERILE . THE SURGEON WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE BY SWITCHING OUT THE INSTRUMENTS AND USING ANOTHER. THERE WAS A 2 MINUTE DELAY. NO PATIENT INJURY WAS REPORTED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459130 14.5MM OUTER PROTECTION SLEEVEFOR SUPRAPATELLAR - STERILE JDS SYNTHES MONUMENT 7069802

    Patients

    Seq Age Sex Outcome Treatment
    1