BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM CANNULATED SCREW PARTIALLY THREADED/50MM

    MDR report key: 3000714 · Received March 12, 2013

    Report

    Report Number
    1719045-2013-10214
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    December 28, 2011
    Report Date
    December 29, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K963172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. 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 PRODUCT DEVELOPMENT VISUAL INSPECTION REVEALED THE RELEVANT FEATURES COULD NOT BE CHECKED IN ENTIRETY DUE TO DAMAGE BUT NO ISSUES WERE FOUND IN SECTIONS THAT COULD BE CHECKED. SINCE NO ISSUES WERE FOUND DURING DIMENSIONAL ANALYSIS AND NO LOT NUMBER WAS PROVIDED THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    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. ORIGINAL AWARENESS DATE: (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THREADS IN 4.5MM CANNULATED SCREW DELAMINATED FROM THE CORE. THE THREADS CAME OFF OF THE SCREW DURING SCREW INSERTION. THE SURGEON BACKED OUT THE SCREW. THE THREADS WERE RETRIEVED FROM INSIDE THE PATIENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103915 4.5MM CANNULATED SCREW PARTIALLY THREADED/50MM HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1