BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER FOR TI ELASTIC NAILS

    MDR report key: 3080876 · Received April 26, 2013

    Report

    Report Number
    8030965-2013-11139
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    November 14, 2011
    Report Date
    November 15, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 INSERTER WAS BROKEN INTO 3 PIECES. THREADED PART OF THE CENTER SHAFT WAS BROKEN AT THE NEXT OF BOTTOM SURFACE OF THE STRIKING HEAD. THE HANDLE WAS REMOVED OFF FROM THE CENTER SHAFT. THE PART OF THREADED AREA ON THE CENTER SHAFT, OUT FROM THE STRIKING HEAD, MAY BECOME THE MOST STRESSED AREA OF THE ITEM. LONG TERM USE MAY CAUSE IT TO REACH THE LIMIT OF THE FATIGUE STRENGTH FOR THE AREA. OR THE HIGHER STRESSED AREA REACHED TO MAXIMUM LIMIT OF ITS STATIC STRENGTH BECAUSE OF OVERLOADED IMPACTING FORCE AT THE STRIKING HEAD. THIS ITEM WAS MANUFACTURED ON JANUARY 2008 WITHOUT DISCREPANCY IN THE SPECIFICATION. THE DESIGN OF THIS LOT WAS OBSOLETE ON OCTOBER 2008 BECAUSE OF DESIGN UPDATE. SINCE THEN, THE DESIGN WAS MODIFIED SEVERAL TIMES TO BE CURRENT VERSION. ONE OF REASONS FOR UPDATING DESIGN WAS THAT SIMILAR COMPLAINTS AS THIS ONE WERE REPORTED MULTIPLE TIMES IN THE PAST. DUE TO THE MARKET FEEDBACK AND IN TERMS OF CONTINUAL IMPROVEMENTS, THIS INSTRUMENT IS CURRENTLY SUBJECTED TO FURTHER MONITORING AND MODIFICATION, AND AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE. IT IS CONCLUDED THAT THIS COMPLAINT IS VALID. THE MANUFACTURING EVALUATION SHOWED THAT THE SHAFT OF THE INSERTER IS BROKEN AT THE THREAD WHICH IS USED TO ATTACH THE HEAD. THE RELEVANT DIMENSIONS, THE INNER AND OUTER DIAMETER OF THE BROKEN SHAFT, WERE CHECKED AND FOUND WITHIN THE SPECIFICATION. THE FRACTURE FACE IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY. THERE ARE EXTREME HAMMER MARKS AT THE TOP, THE CHUCK AND AS WELL AT THE PLASTIC HANDLE VISIBLE. THIS IS AN INDICATION THAT EXCESSIVE HANDLING CAUSED THIS BREAKAGE. NO MANUFACTURING RELATED FAULT COULD BE DETECTED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PEDIATRIC FEMUR PROCEDURE, THE SURGEON WAS INSERTING THE TI ELASTIC NAIL, AND WAS IMPACTING THE INSERTER WITH A MALLET, WHEN THE INSERTER BROKE WHERE THE T-HANDLE AND SHAFT COME TOGETHER. NO PIECES FELL INTO WOUND, AND THERE WAS NOTHING TO RETRIEVE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183237 INSERTER FOR TI ELASTIC NAILS LXH SYNTHES GMBH 1811056

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR