BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAQUET GMBH

    MDR report key: 962864 · Received July 7, 2007

    Report

    Report Number
    8010652-2006-00006
    Event Type
    Other
    Date Received
    July 7, 2007
    Report Date
    June 8, 2006
    Manufacturer
    MAQUET GMBH AND CO. KG
    Product Code
    JEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    NO MECHANICAL PROBLEMS NOTED WITH THE FRACTURE TABLE. PROBLEM WAS DETERMINED TO BE USER ERROR BY CUSTOMER.

    Description of Event or Problem · 1

    DURING PROCEDURE (LEFT INTRAMEDULLARY NAILING OF FEMUR) TO REALIGN A FRACTURE, THE PHYSICIAN INSTRUCTED THE SALES REP (FROM THE CO THAT MFG THE NAIL) TO INCREASE THE TRACTION. WHEN THE SALES REP STARTED TO TURN THE TRACTION HANDLE, A LOUD NOISE WAS HEARD. ALL ATTEMPTS TO INCREASE THE TRACTION CEASED. THE PT'S FOOT HAD PARTIALLY SLIPPED OUT OF THE TRACTION BOOT. THE SURGEON BROKE SCRUB AND SECURED THE LEFT FOOT AGAIN INTO THE TRACTION BOOT. PT DID NOT SUSTAIN ANY INJURY AND THEN PROCEEDED WITH THE SURGERY WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET GMBH ORTHOPEDIC TABLE JEA MAQUET GMBH AND CO. KG 1417.01B *

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR