BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOLT CUTTING HEAD Ø5 LONG CUTTING-H 2 F/

    MDR report key: 3135831 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02485
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    January 20, 2011
    Report Date
    February 4, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. ADDITIONAL NARRATIVE: A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE REVIEW OF THE MANUFACTURING DOCUMENTS REVEALED THAT THE PRESENT INSTRUMENT WAS MANUFACTURED IN FEBRUARY 2003 AND THAT IT CONFORMS TO THE SPECIFICATIONS. THE VISUAL INSPECTION AS PART OF THE INVESTIGATION HAS SHOWN THAT THE BOTTOM OF THE CUTTING HEAD IS BROKEN OFF. THE INVESTIGATION WAS NOT ABLE TO DETERMINE THE EXACT REASON OF THIS DAMAGE. IT IS VERY IMPORTANT THAT THE SCHANZ SCREW IS POSITIONED CORRECTLY BEFORE CUTTING AND THAT VERY FAST CUTTING-PROCEDURES MAY LEAD TO A SHORT TIME OVERLOADING RESULTING IN THE BREAKAGE OF THE BOTTOM OF CUTTING HEAD. IN ADDITION, THIS INSTRUMENT IS SUBJECTED TO COMMON WEAR AND TEAR. AS SOON AS THE CUTTING PROCEDURE GETS HARDER, IT MAY BE INDICATED THAT THE DEVICE SHOULD BE REPLACED. THE BOLT CUTTING HEAD WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. ADDITIONAL COMMON DEVICE CODES: HTZ FZT.

    Description of Event or Problem · 1

    THE BODY OF THE BOLT CUTTER WAS BROKEN OFF DURING CUTTING OF THE SHANTZ SCREW. THE SURGEON WAS UNABLE TO TURN THE BOLT CUTTER TO CUT THE SHANTZ SCREW. THE SURGEON FELT HE USED THE DEVICE ACCORDING TO THE TECHNIQUE MANUAL. THIS IS REPORT 1 OF 1 FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233812 BOLT CUTTING HEAD Ø5 LONG CUTTING-H 2 F/ LXH SYNTHES GMBH 1157772

    Patients

    Seq Age Sex Outcome Treatment
    1