BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTS TRAUMA

    MDR report key: 3171633 · Received June 15, 2013

    Report

    Report Number
    2520274-2013-03193
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    January 23, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. DEVICE WAS RECEIVED AND THE HEAD BROKE OFF DURING INSERTION. THE MICROSCOPIC VIEW OF THE BROKEN SURFACE IS HOMOGENOUS AND DOES NOT SHOW ANY ANOMALIES. BASED ON THE PROVIDED DETAILS AND WITHOUT THE ARTICLE AND LOT NUMBER, A COMPLETE INVESTIGATION IS NOT POSSIBLE. IT DOES NOT APPEAR TO BE A PRODUCT FAULT.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON AN UNKNOWN DATE, THE SURGEON ATTEMPTED INSERTION OF THE MHS 1.5MM SCREW. THE SCREW BROKE JUST BELOW THE SCREW HEAD. THE SCREW SHAFT WAS UNABLE TO BE REMOVED AND WAS LEFT IN THE PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272857 IMPLANTS TRAUMA HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1