BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE HEXAGONAL SCREWDRIVER

    MDR report key: 2983003 · Received February 26, 2013

    Report

    Report Number
    8030965-2013-10239
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED (B)(4) 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFO RECEIVED REGARDING EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. SUBJECT DEVICE HAS BEEN RECEIVED AND EVALUATED. THE MFG RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE SCREW OF THE SYNFRAME CONNECT ROD WAS COMPLETELY SEIZED UP AND IT WAS IMPOSSIBLE TO REMOVE THE SCREW FOR INVESTIGATION. THEREFORE, WE WERE NOT ABLE TO DETERMINE THE CAUSE OF THIS OCCURRENCE. WE CAN ONLY ASSUME THAT THE THREAD WAS PREVIOUSLY DAMAGED AFTER ANOTHER PROCEDURE OR THAT SOME RESIDUES CAUSED THE BLOCKAGE. AS A CONSEQUENCE OF THIS MALFUNCTION, THE TIP OF THE SCREWDRIVER BROKE OFF BY A MECHANICAL OVERLOAD AS IT WAS IMPOSSIBLE TO RELEASE THE SCREW. THIS COMPLAINT IS DEEMED TO BE INDETERMINATE FROM A MFG STANDPOINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A SUCCESSFUL PROCEDURE, THE NURSE DISCOVERED THAT THE SCREW IN THE SYNFRAME CONNECT ROD WAS STUCK. THE LARGE HEXAGONAL SCREWDRIVER WAS THEN USED TO LOOSEN THE SCREW, WHICH DID NOT RELEASE, AND THE TIP OF THE SCREWDRIVER BROKE. NO HARM WAS REPORTED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81250 LARGE HEXAGONAL SCREWDRIVER HXX SYNTHES GMBH 1695668

    Patients

    Seq Age Sex Outcome Treatment
    1