BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE WITH QUICK COUPLING SMALL

    MDR report key: 2875014 · Received December 17, 2012

    Report

    Report Number
    8030965-2012-01598
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Date of Event
    November 18, 2012
    Report Date
    November 18, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K112068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. REPORTED DATE OF IMPLANT WAS (B)(6) 2012. DEVICE IS AN INSTRUMENT AND THEREFORE IS NOT IMPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RECEIVED AND THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A MANUFACTURING EVALUATION WAS CONDUCTED AND THE REPORT INDICATES THE END CAP ON THE HANDLE OF THE SCREW DRIVER WAS SEPARATED FROM THE HOLDING MECHANISM. THE END CAP SHOWS MARKS OF HAMMERING. THE END CAP ON THE HANDLE OF THE SCREW DRIVER WAS SEPARATED FROM THE HOLDING MECHANISM. THE END CAP SHOWS MARKS OF HAMMERING. THE END CAP HOLDING JAWS ON THE HANDLE ARE DEFORMED. DUE TO THE DAMAGE THE DIMENSIONS CANNOT BE CHECKED TO POST-MANUFACTURING DIMENSIONS ANYMORE. THE DHR REVIEW SHOWS THAT THE INSTRUMENT MET THE SPECIFICATIONS AT THE TIME OF MANUFACTURING AND DISTRIBUTING. A PRODUCT DEVELOPMENT EVALUATION WAS ALSO CONDUCTED AND THE REPORT INDICATES IT WAS ESTABLISHED THAT ON THE RETURNED INSTRUMENT THE END CAP FELL OFF. HOWEVER, UPON FURTHER INSPECTION IT WAS DETECTED THAT THE WINGS INSIDE OF THE CAP WERE DEFORMED. THE CAP ITSELF SHOWS MARKS WHICH INDICATE THAT A METAL HAMMER WAS USED ON THE INSTRUMENT. EXCESSIVE USE OF A HAMMER MIGHT HAVE CAUSED THE WINGS TO BE DEFORMED; HENCE CAUSING DAMAGE OF THE MECHANISM. THE INSTRUMENT WAS MISHANDLED.

    Description of Event or Problem · 1

    DURING A PROCEDURE SURGEON WAS USING THE HANDLE WITH QUICK COUPLING AND THE SILVER PIECE AT THE BOTTOM CAME OFF, SURGEON RETRIEVED THE PIECE. DEVICE WAS STILL FUNCTIONAL; SURGEON WAS ABLE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANDLE WITH QUICK COUPLING SMALL HANDLE WITH QUICK COUPLING OVE SYNTHES GMBH 3363449

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR