BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JARIT BONE HOOK 3/5" (19MM)

    MDR report key: 668443 · Received January 19, 2006

    Report

    Report Number
    2430952-2006-00003
    Event Type
    Malfunction
    Date Received
    January 19, 2006
    Report Date
    January 18, 2006
    Manufacturer
    OERTEL MEDIZINTECHNIK GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A DISTRIBUTOR THAT THE SURGEON WAS PERFORMING A SUBACROMIAL DECOMPRESSION IN 2005. HE HAD JUST INSERTED THE BONE HOOK AND WAS BEGINNING TO APPLY PRESSURE WHEN THE INSTRUMENT BENT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JARIT BONE HOOK 3/5" (19MM) MANUAL SURGICAL INSTRUMENT LXH OERTEL MEDIZINTECHNIK GMBH 240-196 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *