BEUDAMED
    FDA Adverse Event Other Summary report: N

    TIBIAL STABILIZING ROD

    MDR report key: 1784989 · Received February 16, 2010

    Report

    Report Number
    9680825-2010-00002
    Event Type
    Other
    Date Received
    February 16, 2010
    Date of Event
    November 25, 2009
    Report Date
    February 16, 2010
    Manufacturer
    ORTHOFIX SRL
    Product Code
    HSB
    PMA / PMN Number
    K053261
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS SUBJECT TO VISUAL, DIMENSIONAL, MECHANICAL AND FAILURE ANALYSIS. THE TECHNICAL ANALYSIS PERFORMED ON THE RETURNED DEVICE EVIDENCED ITS COMPLIANCE TO ORTHOFIX DESIGN AND PRODUCT SPECS. AS NO INFO HAS BEEN PROVIDED BY THE HOSPITAL ON THE SPECIFIC APPLICATION, IT IS NOT POSSIBLE TO CONDUCT A ROOT CAUSE ANALYSIS. THE ONLY ASSUMPTION WE CAN MAKE IS THAT, AS IT WAS PROVED THAT THE RETURNED PRODUCT COMPLIES WITH ORTHOFIX SPEC, THE STABILIZING ROD WAS PROBABLY SUBJECT TO ONE OR REPEATED OVERLOADS DURING THE INSERTIONS. ORTHOFIX CONTINUES MONITORING THE PRODUCTS ON THE MARKET. IN CASE ADDITIONAL INFO WILL BECOME AVAILABLE, ORTHOFIX WILL PROMPTLY REOPEN THE INVESTIGATION.

    Description of Event or Problem · 1

    DURING THE DISTAL LOCKING OF THE CENTRONAIL, THE THREADED PART OF THE TIBIAL STABILIZING ROD BROKE. THE BROKEN PART WAS LEFT IN THE NAIL, NO PT ADVERSE EFFECTS. MFR REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIBIAL STABILIZING ROD TIBIAL STABILIZING ROD HSB ORTHOFIX SRL 174031 G007

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK