BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD REDUCER

    MDR report key: 1873465 · Received October 14, 2010

    Report

    Report Number
    1038671-2010-00163
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    September 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    EXACTECH, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING EVALUATION OF THE RETURNED INSTRUMENT NOTED THAT THE LOCKING PIN WOULD EITHER ALLOW THE INSTRUMENT TO LOCK OR FAIL TO LOCK DEPENDING ON THE ROTATIONAL ORIENTATION OF THE PIN. THE LOCKING PIN FUNCTIONS BY BEING FORCED INTO A SLOT BY SPRING FORCE WHEN THE MEMBER THAT LOCKS ONTO THE SCREW HEAD IS LOCATED AT THE PROPER AXIAL POSITION. FAILURE OF THE PIN TO RETAIN THIS LOCK IMPLIES POSSIBLE WEAR THAT AFFECTS THE ABILITY TO POSITIVELY RETAIN OR DEFORMATION THAT DOESN'T PERMIT THE PIN TO ENGAGE THE LOCKING SLOT. ALTERNATIVELY, WHEN THE LOCKING PIN IS ENGAGED AND THEN ROTATED CLOCKWISE ONE OF TWO EVENTS HAPPEN: THE LOCKING MECHANISM DISENGAGES, WHICH MAY BE CAUSED BY WEAR OF THE PIN AS PREVIOUSLY MENTIONED OR THE PIN ROTATES UNTIL NOTABLE RESISTANCE IS FELT; ATTEMPTS TO PULL THE LOCKING PIN TO UNLOCK THE INSTRUMENT ARE EXTREMELY DIFFICULT. WEAR AND/OR DEFORMATION OF THE LOCKING PIN FROM REPEATED USE IS LIKELY THE ROOT CAUSE. A DHR REVIEW INDICATES THIS PART HAS BEEN PREVIOUSLY REWORKED TO THE MOST CURRENT REVISION; THERE IS NO INDICATION OF NONCONFORMITIES TO DEVICE SPECIFICATION.

    Description of Event or Problem · 1

    DURING SURGERY, ROD REDUCER WOULD NOT DISENGAGE FROM THE SADDLE OF THE PEDICLE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROD REDUCER LXH EXACTECH, INC. 070010R

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention