BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE INSERTER

    MDR report key: 3030904 · Received April 2, 2013

    Report

    Report Number
    2530088-2013-10298
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    September 14, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE HELICAL BLADE INSERTER WAS RETURNED FOR A PRODUCT DEVELOPMENT EVALUATION AND THE SET SCREW WAS BROKEN OFF AND THE END WAS STILL IN THE ALIGNMENT INDICATOR. THE ALIGNMENT INDICATOR WAS STILL ATTACHED SECURELY TO THE INSERTER. THERE WERE NUMEROUS DINGS AND GOUGES FROM HAMMER STRIKES ON THE GOLD HANDLE, THE TOP AND BOTTOM OF THE ALIGNMENT INDICATOR EARS, AND ON THE KNURLED SURFACE OF THE SET SCREW. THIS COMPLAINT CONDITION IS CAUSED BY INADVERTENT HAMMER BLOWS TO THE ALIGNMENT INDICATOR, HAS BEEN PREVIOUSLY EVALUATED, AND WAS DETERMINED TO BE INVALID.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THE TIP WAS BROKEN ON THE CANNULATED 4.0 MM HEXAGONAL SCREWDRIVER. ADDITIONALLY, THE HELICAL BLADE INSERTER SCREW WAS BROKEN AND DID NOT WORK CORRECTLY. THIS IS REPORT 2 OF 2 FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134515 HELICAL BLADE INSERTER LXH SYNTHES BRANDYWINE 6410076

    Patients

    Seq Age Sex Outcome Treatment
    1