BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVER W/T-HANDLE STD F/MATRIX 5.5

    MDR report key: 3162516 · Received June 11, 2013

    Report

    Report Number
    1719045-2013-01590
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 5, 2011
    Report Date
    May 6, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. 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. (B)(6). IT IS PRESUMED THAT IN THIS PRESENT CASE, THE WRONG INSTRUMENT WAS USED AND IT CAUSED THIS DAMAGE. FURTHER INVESTIGATION USING THE MATERIAL AND MANUFACTURE DOCUMENTS DID NOT POINT TO ANY DEVIATIONS FROM THE SPECIFICATIONS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN UNKNOWN SURGERY THE TIP OF THE T HANDLE BROKE OFF DURING LOOSENING. THE TIP REMAINED IN THE SCREW HEAD. THE ROD NEEDED TO BE CUT AND BOTH THE ROD AND SCREW HAD TO BE REPLACED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262446 SCRDRIVER W/T-HANDLE STD F/MATRIX 5.5 HXX SYNTHES MONUMENT 6186137

    Patients

    Seq Age Sex Outcome Treatment
    1