BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITST FIXATION THREADED GUIDE PIN

    MDR report key: 2519926 · Received April 4, 2012

    Report

    Report Number
    1822565-2012-00685
    Event Type
    Injury
    Date Received
    April 4, 2012
    Date of Event
    February 25, 2012
    Report Date
    March 5, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THERE ARE SCRATCHES ON THE SHAFT OF THE PIN AS WELL AS EXTENSIVE DAMAGE ON THE THREADS. DIMENSIONS TAKEN ARE WITHIN SPEC. THE AGE OF THE PIN IS UNK AND THE USAGE HISTORY IS UNK. DETAILS OF SURGICAL TECHNIQUE USED ARE UNK. THERE IS INSUFFICIENT INFO PROVIDED TO DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. THIS PRODUCT WILL BE MONITORED FOR ANY ADVERSE COMPLAINT TRENDS. AS RETURNED, THE TIP IS FRACTURED AT THE THREADED PORTION. THERE ARE SCRATCHES ON THE SHAFT OF THE PIN AS WELL AS EXTENSIVE DAMAGE ON THE THREADS. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE TIP OF THE GUIDE WIRE BROKE OFF AND WENT INTO THE PT DURING AN ITST CASE. ANOTHER INCISION WAS MADE IN ORDER TO RETRIEVE THE BROKEN TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITST FIXATION THREADED GUIDE PIN LXH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention