BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    17MM REAMER W/STOP F/2.4MM VALINTERCARPAL FUSION PLATE

    MDR report key: 2890491 · Received December 31, 2012

    Report

    Report Number
    8030965-2012-01717
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K103243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DURING A 4 COLUMN CARPAL FUSION PROCEDURE, THE SURGEON COMPLAINED THAT THE REAMER WAS DULL. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITH THE DULL REAMER WITHOUT DELAY. REPORTEDLY THE PROCEDURE WAS COMPLETED WITH NO NEGATIVE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 17MM REAMER W/STOP F/2.4MM VALINTERCARPAL FUSION PLATE 17MM REAMER W/STOP HRS SYNTHES GMBH 2683551

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR