BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WASHER Ø13/6.6 F/SCR Ø4.5-7.3 TI

    MDR report key: 3171583 · Received June 15, 2013

    Report

    Report Number
    2520274-2013-03192
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    October 24, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    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. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION HAS SHOWN THAT THE LOWER RIM OF THE PRESENT WASHER IS DEFORMED. IN ADDITION, THE EXACT LOT NUMBER IS NOT KNOWN, THEREFORE, THE PRESENT COMPLAINT CANNOT BE FULLY ANALYZED. WE ARE NOT ABLE TO GIVE A CONCLUSIVE STATEMENT REGARDING A POSSIBLE FAILURE REASON. HOWEVER, THE INNER DIAMETER OF THE DAMAGED WASHER IS STILL SMALLER THAN THE HEAD OF A CSS SCREW, AND WE CAN ONLY ASSUME THAT A MECHANICAL OVERLOAD DURING PROCEDURE CAUSED THIS PHENOMENON.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING INSERTION OF THE SCREW ON AN UNKNOWN DATE, THE CSS SCREW 7.3 PULLED THROUGH THE WASHER. 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
    272587 WASHER Ø13/6.6 F/SCR Ø4.5-7.3 TI NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1