BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVER F/EXTRACT

    MDR report key: 3171581 · Received June 15, 2013

    Report

    Report Number
    1719045-2013-01550
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    June 17, 2011
    Report Date
    June 30, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. THE INVESTIGATION OF THE COMPLAINED SCREWDRIVER SHOWS THAT THE TIP IS BROKEN OFF DUE TO MECHANICAL OVERLOADING DURING USAGE. THE INNER SHAFT WAS NOT RETURNED AND DISPOSED BY THE HOSPITAL. THE BREAKAGE IS INDICATIVE OF TOO MUCH APPLIED MECHANICAL FORCE DURING USAGE WHICH HAS LED TO THIS DAMAGE. FURTHER INVESTIGATION REGARDING THE MANUFACTURING DOCUMENTS SHOW CONFORMITY TO THE SPECIFICATION. THE BROKEN SURFACE ITSELF IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY AS WELL. NO PRODUCT FAULT COULD BE DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    SCREWDRIVER WAS BROKEN DURING A SCREW REMOVAL. THIS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272440 SCRDRIVER F/EXTRACT HXX SYNTHES MONUMENT 607187E09

    Patients

    Seq Age Sex Outcome Treatment
    1