BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM CORTEX SCREW SELF-TAPPING 34MM

    MDR report key: 3035370 · Received April 4, 2013

    Report

    Report Number
    1719045-2013-10517
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    May 11, 2012
    Report Date
    May 11, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. 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. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES DZL. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    DEVICE NOT IMPLANTED. MANUFACTURING SITE ADDRESS IS UNKNOWN. ORIGINAL AWARENESS DATE IS (B)(6) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE LOCKING COMPRESSION PLATE ELBOW MARKET PREFERENCE EVALUATION (MPE), TWO 2.7 CORTICAL SCREWS WERE INSERTED INTO THE DISTAL HUMERUS BONE AND THE SCREW HEADS TWISTED OFF THE SHAFT OF THE SCREWS. NO COMPLICATIONS AND NO PATIENT HARM WERE NOTED. IT IS UNKNOWN IF THE SCREWS WERE REPLACED. THIS IS REPORT 2 OF 2 FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS REPORT IS FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138076 2.7MM CORTEX SCREW SELF-TAPPING 34MM HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR