BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP BODY/FOR RADIOLUCENT INSERTION HANDLE

    MDR report key: 3031819 · Received April 2, 2013

    Report

    Report Number
    2530088-2013-10323
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    May 29, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. MANUFACTURING EVALUATION REPORTS THAT THE CAP BODY WAS RECEIVED WITH THE THREADED TIP SHEARED OFF. THE PARTS SHOWED SIGNS OF NORMAL WEAR WITH IMPACT MARKS ON THE DRIVING HEAD. THE THREADED SHAFT DIAMETER WAS MEASURED AT THE SHEAR LOCATION AND THE PART MEETS PRINT AT 6.04 DIA. NO CONCLUSION CAN BE MADE WHETHER THE CAP BODY OVER TIGHTENED OR NOT FULLY THREADED INTO THE HANDLE. AS A RESULT THIS COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    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. (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TROCHANTERIC FIXATION NAIL (TFN) WHILE INSERTING THE NAIL, ON THE LAST HIT, THE DRIVING CAP BROKE OFF IN THE HANDLE. THE PATIENT WAS UNHARMED. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE, WHILE INSERTING THE NAIL DURING A TFN , ON THE LAST HIT THE DRIVING CAP BROKE OFF IN THE HANDLE. THE STRIKE HANDLE WAS NOT FULLY SEATED AND WAS LEFT A LITTLE LOSE BY SURGEON FOR QUICK, EASY REMOVAL DURING X-RAY AND THE REPEATED STRIKES WITH THE HAMMER TO INSERT THE NAIL OVER TIME BROKE THE STRIKE HANDLE AT THE BASE WHERE IT MEETS THE INSERTION HANDLE THUS LEAVING THE THREADS OF THE INSTRUMENT IN THE INSERTION HANDLE. NO HARM TO PATIENT. BOTH ITEMS ARE EARLY RELEASE, LOW VOLUME ITEMS. PD ADVISED CONSULTANT OF CURRENT REPLACEMENT PART NUMBERS FOR COMPLAINED ITEMS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133885 DRIVING CAP BODY/FOR RADIOLUCENT INSERTION HANDLE LXH SYNTHES BRANDYWINE 6448816

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR