BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE FOR PROTECTION SLEEVES

    MDR report key: 3051867 · Received April 10, 2013

    Report

    Report Number
    2530088-2013-10410
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    October 3, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PARAMEDIC

    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT DEVELOPMENT EVALUATION REVEALED THAT THE WING NUT WAS BROKEN OFF AS DESCRIBED IN THE COMPLAINT. THERE IS A GOUGE AT THE EDGE OF THE HOLE WHERE THE WING NUT MOUNTED ON THE INSTRUMENT. THERE ARE SOME MINOR SCRATCHES ON THE HEAD. THERE ARE NO PRIOR COMPLAINTS IN THE 2 YEAR HISTORY AND THE COMPLAINT CONDITION PRESENTS MINIMAL RISK. THE THUMB SCREW IS STAKED AT THE BASE SO THE REMAINING PORTION CANNOT FALL OUT OF THE SLEEVE. THE SUBJECT DEVICE WAS MANUFACTURED IN AUGUST 2000 AND AT THAT TIME, THE INSIDE PART THAT ENGAGED THE INSTRUMENT SHAFT WAS A SPRING LOADED BALL PLUNGER. THEREFORE, EVEN IF THE TOP OF THE SCREW BROKE OFF, THE BALL DETENT WOULD PROVIDE THE DESIRED RETENTION. THERE IS A MARK ON THE HEAD AT THE BASE OF THE HOLE WHERE THE THUMB SCREW WAS LOCATED WHICH INDICATES THAT THE THUMB SCREW WAS BROKEN BECAUSE OF MISUSE RATHER THAN A DESIGN OR MANUFACTURING RELATED ISSUE. THEREFORE THIS COMPLAINT IS INVALID. PLACEHOLDER.

    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. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN IM NAILING PROCEDURE, HOSPITAL ACCOUNT ADVISED THAT THE WING NUT WAS FOUND BROKEN OFF. IT IS NOT KNOWN HOW OR WHEN THE WING NUT BROKE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR THIS COMPLAINT (B)(4). REPORT WAS FOR AN INTER-MEDULLARY NAILING (IM) PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152232 HANDLE FOR PROTECTION SLEEVES LXH SYNTHES BRANDYWINE 4150020

    Patients

    Seq Age Sex Outcome Treatment
    1