BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTN HANDLE F/3.5MM LOW BNDMEDIAL DISTAL TIB PLATE/RIGHT

    MDR report key: 3082707 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11169
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    July 12, 2012
    Report Date
    July 12, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 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 DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THE HEAD OF THE CONNECTION SCREW IS BROKEN OFF AND WAS NOT SENT BACK FOR INVESTIGATION. THREADED REMAINDER OF THE SCREW IS JAMMED IN THE HANDLE. NOT ALL RELEVANT DIMENSIONS CAN BE VERIFIED ANYMORE BECAUSE THE BROKEN FRAGMENT WAS NOT SENT BACK FOR INVESTIGATION AND AS THE THREAD IS JAMMED IN THE HANDLE. THEREFORE THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT. FROM THE COMPLAINT DESCRIPTION, IT IS NOT POSSIBLE TO DETERMINE THE STATIC/FATIGUE LOADING ON THE ATTACHING SCREW NOR THE AMOUNT OF TIMES THE ATTACHING SCREW MIGHT HAVE BEEN USED BEFORE THE FAILURE, OR IF IT WAS CROSS THREADED. THE DESIGN WAS EVALUATED AND DEEMED ADEQUATE, THEREFORE THE COMPLAINT IS INVALID.

    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. ORIGINAL AWARENESS DATE IS (B)(4) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DISTAL TIBIA FRACTURE CONNECTING SCREW BROKE WHEN THE TECH WAS SETTING UP ON THE BACK TABLE. THE SURGEON USED OTHER INSTRUMENTS AND COMPLETED THE PROCEDURE. THE COMPLAINED INSTRUMENT NEVER HAD ANY CONTACT WITH PATIENT, SO NO HARM TO PATIENT OR NO EXTENSION OF TIME. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184539 INSERTN HANDLE F/3.5MM LOW BNDMEDIAL DISTAL TIB PLATE/RIGHT FZX SYNTHES GMBH 3639967

    Patients

    Seq Age Sex Outcome Treatment
    1