BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM FLEXIBLE MEDULLARY REAMER/FLAT WIRE/385MM

    MDR report key: 3131819 · Received May 29, 2013

    Report

    Report Number
    1719045-2013-01446
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    January 4, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K971544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE PRESENT MEDULLARY REAMER WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED. NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON CONFORMANCES AND AS NO DETAILED CLINICAL INFORMATION IS AVAILABLE. THE BREAKAGE IS POSSIBLY INDICATIVE OF OVERLOADING DURING USAGE. PLACEHOLDER.

    Description of Event or Problem · 1

    THE HEAD BROKE OFF DURING USAGE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234954 7.0MM FLEXIBLE MEDULLARY REAMER/FLAT WIRE/385MM HTO SYNTHES MONUMENT 6318660001

    Patients

    Seq Age Sex Outcome Treatment
    1