BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIDE HAMMER FOR HAMMER GUIDE

    MDR report key: 2972533 · Received February 21, 2013

    Report

    Report Number
    2530088-2013-10101
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 8, 2012
    Report Date
    January 8, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    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 INFORMATION: THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). (B)(4).

    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 INFORMATION: A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED AND THE ISSUE WITH THE LOCKING MECHANISM BEING ENGAGED PRIOR TO INSERTION OF THE HELICAL BLADE HAS BEEN REVIEWED ON SEVERAL PRIOR COMPLAINTS AND IT HAS BEEN DETERMINED THAT THE HELICAL BLADE DOES NOT CONTRIBUTE TO THAT COMPLAINT CONDITION. THE KEY FEATURES WERE CHECKED ON THE RETURNED BLADE AND ALL WERE WITHIN TOLERANCE AND IT WAS SUCCESSFULLY INSERTED THROUGH A TFN NAIL. THE HAMMER WAS MANUFACTURED IN APRIL 2005 AND IS OVER 6 1/2 YEAR OLD. THE HAMMER IS USED WITH THE HAMMER GUIDE AND, WHEN USED CORRECTLY, ALL THE STRIKING IS DONE IN THE CENTRAL PORTION OF THE HAMMER FACE. THERE ARE THREE VERY LARGE DENTS IN THE EDGE AND OUTER DIAMETER OF THE HAMMER WHICH INDICATES THAT IT WAS DROPPED OR USED IN A MANNER THAT IS NOT CONSISTENT WITH THE RECOMMENDED TECHNIQUE. GIVEN THE WEIGHT OF THE HAMMER, THE AGE, AND THE FORCE NECESSARY TO DAMAGE THE HAMMER IN SUCH A WAY, THE HANDLE WAS MOST LIKELY DAMAGED WHEN THAT HAPPENED AND THE BREAK COMPLETED DURING THE NOTED USE. CONCLUSION: PREVIOUS COMPLAINTS HAVE CONCLUDED THAT THE BLADE DOES NOT CONTRIBUTE TO THE ISSUE IF THE LOCKING MECHANISM IN THE NAIL IS ENGAGED PRIOR TO INSERTION. THE ISSUE WITH THE HAMMER WAS CAUSED BY MISUSE. THEREFORE, THERE ARE NO INDICATIONS OF ANY MANUFACTURING OR DESIGN RELATED ISSUES WITH EITHER OF THE RETURNED PARTS. AS THE REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT, THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE AND AS REVEALED DURING THE DEVICE INVESTIGATION, THE DAMAGE WAS CAUSED BY BEING DROPPED OR USED IN A MANNER THAT IS NOT CONSISTENT WITH THE RECOMMENDED TECHNIQUE. THEREFORE THIS COMPLAINT IS INVALID AND USER ERROR CONTRIBUTED TO THE EVENT. YES, DEVICE WAS RETURNED AND EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE, THE SLIDE HAMMER HANDLE BROKE. ALL PIECES WERE RETRIEVED AND THE PROCEDURE WAS COMPLETED.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76557 SLIDE HAMMER FOR HAMMER GUIDE LXH SYNTHES BRANDYWINE 4963278

    Patients

    Seq Age Sex Outcome Treatment
    1