BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM CANNULATED LOCKING SCREW50MM

    MDR report key: 3082691 · Received April 29, 2013

    Report

    Report Number
    1719045-2013-10940
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    June 20, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K000066
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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)

    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. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED TAHT THE SCREW IS IN LIKE NEW CONDITION WITH NO VISIBLE WEAR OR DAMAGE. THE SCREW IS A 4.0 MM LOCKING SCREW AND IS 46 MM LONG. THE RETURNED PART IS A 46 MM LONG 4.0 MM LOCKING SCREW (NON-CANNULATED) AND THE COMPLAINT REPORTS THAT THE PART WAS LABELED AS A 50 MM LONG 5.0 MM CANNULATED LOCKING SCREW. THE PACKAGING WAS NOT RETURNED SO THE COMPLAINT CONDITION CANNOT BE VERIFIED. SINCE THE PACKAGING WAS NOT RETURNED, THE COMPLAINT CONDITION CANNOT BE VERIFED AND THEREFORE THE COMPLAINT IS INDETERMINATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 5.0MM CANNULATED LOCKING SCREW 50MM WAS ORDERED AND THE ITEM # ON THE PACKAGE DOES NOT MATCH THE PART INSIDE OF THE PACKAGE. THE SCREW INSIDE THE PACKAGE DOES NOT HAVE A HOLE THROUGH THE CENTER OF THE SCREW. NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185866 5.0MM CANNULATED LOCKING SCREW50MM HWC SYNTHES MONUMENT 6936371

    Patients

    Seq Age Sex Outcome Treatment
    1