BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOOK MCO205D 0.3MM 90DEG 165MM LFT ANG

    MDR report key: 7038139 · Received November 16, 2017

    Report

    Report Number
    2523190-2017-00143
    Event Type
    Malfunction
    Date Received
    November 16, 2017
    Report Date
    October 26, 2017
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    JYL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON NOVEMBER 14, 2017. RESULTS: EVALUATION OF RETURNED DEVICE; THE HOOK IS BROKEN. THE FRAGMENT WAS NOT RECOVERED. A THOROUGH OBSERVATION OF BREAKAGE AREA DID NOT HIGHLIGHTED MATERIAL OR MANUFACTURING DEFECT. THE ETCHING WAS DONE WITH PREVIOUS TECHNOLOGY THAT WAS STOPPED ON 2002. DHR REVIEW; UNABLE TO REVIEW THE APPLICABLE DHR AS THE LOT NO. WAS UNAVAILABLE. COMPLAINTS HISTORY; NO ADVERSE TREND - FIRST OCCURRENCE OF THIS RISK FOR THIS DEVICE. CONCLUSION: THIS DEVICE WAS MANUFACTURED BEFORE 2002 AND NO MAINTENANCE WAS PERFORMED BY THE INTEGRA SERVICE AND REPAIR. THE AGE OF THE INSTRUMENT AND THE LACK OF MAINTENANCE LET REASONABLY CONCLUDE THAT THIS EVENT IS NOT ATTRIBUTABLE TO INTEGRA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT'S HOOK BROKE DURING SURGERY. THE HOOK WAS ON THE DEVICE WHEN THE SURGERY BEGAN, BUT IT WAS NOT THERE WHEN STARTING THE INCISION. IT WAS IMPOSSIBLE TO DETERMINE IF THE HOOK WAS IN THE INTERNAL PART OF THE PATIENT'S EAR. THE HOOK IS FERROMAGNETIC AND THEY COULD NOT PERFORM A MRI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815464 HOOK MCO205D 0.3MM 90DEG 165MM LFT ANG PFM11 JYL INTEGRA MICROFRANCE S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1