BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE HEXAGONAL SCREWDRIVER LONG

    MDR report key: 3083463 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11050
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    August 3, 2012
    Report Date
    August 3, 2012
    Manufacturer
    SYNTHES
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    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 RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. PRODUCT EVALUATION SHOWED THE RETURNED DEVICE WAS MANUFACTURED IN 1995 AND IS APPROXIMATELY 17 YEARS OLD. THIS IS THE ONLY COMPLAINT FOR THIS CONDITION ON THIS DEVICE IN THE 2 YEAR HISTORY AND APPROXIMATELY 167 HAVE BEEN SOLD IN THE SAME TIMEFRAME WHICH RESULTS IN A COMPLAINT RATE OF 0.60 PERCENT BASED ON SALES. THIS DEVICE IS USED REPEATEDLY SO THE ACTUAL RATE BASED ON USAGE WOULD BE SIGNIFICANTLY LOWER. THE CURRENT RISK ANALYSIS SE290530, VERSION AA ADEQUATELY ADDRESSES THIS COMPLAINT CONDITION AS LESS SEVERE WITH A MAJOR SEVERITY OF HARM 4 AND AN IMPROBABLE PROBABILITY OF OCCURRENCE 1. IN CONCLUSION, BECAUSE THIS DEVICE IS APPROXIMATELY 17 YEARS OLD, REPEATEDLY USED AND IS THE ONLY COMPLAINT FOR THIS CONDITION IN THE 2 YEAR HISTORY, THIS COMPLAINT IS INVALID FROM A DESIGN PERSPECTIVE.

    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. DHR WAS NOT AVAILABLE SINCE THE DEVICE WAS 15 YEARS OLD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DISTAL FEMUR PROCEDURE, AS THE SURGEON WAS INSERTING A SCREW THE END OF THE SCREWDRIVER BROKE OFF AND GOT STUCK IN THE SCREW. THE SURGEON USED A HEMOSTAT TO REMOVE THE PART OF THE SCREWDRIVER THAT WAS STUCK IN THE SCREW HEAD. ALL PIECES WERE RETRIEVED. THE SCREW IS INTACT AND REMAINS IN THE PATIENT. THE SURGEON COMPLETED THE PROCEDURE WITHOUT FURTHER INCIDENT AND WITH NO ADVERSE EVENT TO THE PATIENT NOTED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185718 LARGE HEXAGONAL SCREWDRIVER LONG HXX SYNTHES 1006

    Patients

    Seq Age Sex Outcome Treatment
    1