BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE COUPLING SCREW

    MDR report key: 3220592 · Received July 11, 2013

    Report

    Report Number
    2520274-2013-04239
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    SYNTHES
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT DIAGNOSIS. ADDITIONAL NARRATIVE: DHR - A REVIEW OF THE DHR INDICATES THERE WAS ONE MRR (B)(4) FOR TWO PARTS OUT OF 47 IN WHICH THE PIN WILL NOT PASS THROUGH THE PART, OR PIN FUNCTION NONCONFORMING. THE ENTIRE LOT WAS RETURNED TO THE SUPPLIER FOR REWORK AND INSPECTED 100 PERCENT FOR PIN FUNCTION AFTER REWORK AND ALL PASSED. THIS PIN FUNCTION NONCONFORMITY IS NOT RELATED TO THE BREAKAGE COMPLAINT. THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. ALL RECORDS INDICATE THE PRODUCT SHIPPED WAS MANUFACTURED TO SPECIFICATIONS. PRODUCT DEVELOPMENT EVALUATION: DESIGN CHANGES HAVE BEEN MADE TO ADDRESS THE BREAKAGES OF THE COUPLING SCREW. HEAT TREATMENT OF THE INSTRUMENT WAS ADDED IN 2004 TO ADDRESS STRENGTH REQUIREMENTS. THIS SUBMITTED COMPLAINT PART HAS HAD A 6 YEAR SERVICE LIFE. THE COUPLING SCREW HAD A SERVICE LIFE OF 6 YEARS. BASED ON THIS LENGTH OF USE AND OCCURRENCE RATE/COMPLAINT HISTORY, THE DESIGN OF THE DEVICE WAS EVALUATED AND DEEMED TO MEET ITS INTENDED USE. HOWEVER, THE CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DURING A TROCHANTERIC FIXATION NAILING, THE END OF A HELICAL BLADE COUPLING SCREW SNAPPED OFF HITTING THE FLOOR. THIS IS THE DISTAL END THAT IS TAPPED ON. THE END OF THE SCREW WAS STILL SCREWED INTO THE INSERTER. A SCREW REMOVAL KIT WAS USED TO DISENGAGE COUPLING SCREW. PROCEDURE WAS COMPLETED WITH 10 MINUTE DELAY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321047 HELICAL BLADE COUPLING SCREW LXH SYNTHES 5241191

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR