BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QC Ø1-4 F/TRS

    MDR report key: 3021276 · Received March 26, 2013

    Report

    Report Number
    2520274-2013-01696
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 26, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. A MANUFACTURING AND/OR PRODUCT INVESTIGATION COULD NOT BE PERFORMED AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION WAS CONDUCTED AND IT STATES THAT THE COMPLAINT WAS CLOSED WITHOUT A REPORT BECAUSE NO MATERIAL HAS BEEN RETURNED. AN INTERNAL INVESTIGATION WAS COMPLETED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: OIL FLUID LEAKED FROM DEVICE. ON (B)(6) 2013, PRIOR TO THE START OF A TIBIAL DIAPHYSIS FRACTURE PROCEDURE, THE SURGEON FOUND WHITE OIL ATTACHED TO THE MAIN BODY OF THE TRAUMA RECON SYSTEM AROUND THE RENTED OUT RADIO LUCENT DRIVE. THE DEVICE WAS STERILIZED THE DAY PRIOR TO SURGERY. AT THE DOCTORS DISCRETION THE DEVICE WAS CLEANED AND STERILIZED AGAIN. THE DOCTOR THOUGHT THE GREASE MIGHT HAVE LEAKED FROM THE INSIDE OF THE DEVICE. THIS IS 5 OF 6 REPORTS FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THIS IS 5 OF 6 REPORTS FOR THE SAME EVENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124397 QC Ø1-4 F/TRS HWE SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR