BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE COUPLING SCREW

    MDR report key: 3081684 · Received April 29, 2013

    Report

    Report Number
    2530088-2013-10551
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    November 9, 2011
    Report Date
    November 9, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    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 NARRATIVE: A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND REVEALED THAT THIS ARTICLE WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. THE PRODUCT DEVELOPMENT EVENT EVALUATION REPORTED THE FOLLOWING: A REVIEW OF THE PRODUCT DESIGN/DRAWINGS ALSO SHOWED THE COUPLING SCREW DESIGN TO BE ACCEPTABLE FOR THE INTENDED USE. ADDITIONALLY, EXCESSIVE HAMMERING OF THE COUPLING SCREW OFF-ANGLE OR WHEN THE SCREW IS NOT FULLY TIGHTENED, PER THE DESCRIBED TECHNIQUE GUIDE COULD RESULT IN LOADING CONDITIONS THAT MAY LEAD TO BREAKAGE. THE RETURNED HELICAL BLADE COUPLING SCREW (LOT #5194962) WAS MANUFACTURED IN AUGUST 2006 AND IS OVER 6 YEARS OLD AND SHOWS EVIDENCE OF BEING USED AND HAMMERED EXTENSIVELY OVER THAT TIME. THE VISUAL DENTS AROUND THE PERIMETER OF THE HEAD INDICATE THAT IT HAS BEEN STRUCK OFF-ANGLE NUMEROUS TIMES. THE HELICAL BLADE COUPLING SCREW AND HELICAL BLADE DESIGNS WERE REVIEWED AND DETERMINED TO BE ACCEPTABLE FOR THE INTENDED USE. THE MOST PROBABLE CAUSE FOR THIS COMPLAINT IS THAT THE TFN LOCKING MECHANISM WAS DEPLOYED PREMATURELY AS A RESULT OF THE REPROCESSING RECALL. THE HELICAL BLADE COUPLING SCREW AND HELICAL BLADE DESIGNS WERE REVIEWED AND DETERMINED TO BE ACCEPTABLE FOR THE INTENDED USE AND THEREFORE THE COMPLAINT IS INVALID WITH RESPECT TO DESIGN. THE DEVICE IS A COUPLING SCREW THAT HOLDS THE HELICAL BLADE TO THE INSERTER AND IS A REUSABLE INSTRUMENT NEW INFORMATION WAS RECEIVED ON (B)(4) 2012 (DEVICE HISTORY REVIEW) AND (B)(4) 2013 (PRODUCT DEVELOPMENT EVENT EVALUATION. ) PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TFN, TROCHANTERIC FIXATION NAIL PROCEDURE THE SURGEON WAS INSERTING A HELICAL BLADE INTO THE NAIL AND IT WAS HITTING THE LOCKING DEVICE, WHICH WAS IN THE DOWN POSITION. SURGEON USED A MALLET TO HIT THE BLADE INTO THE CONNECTING SCREW AND THE HEAD BROKE OFF THE CONNECTING SCREW. SURGEON REMOVED THE BLADE AND SCREW AND USED ANOTHER BLADE AND SCREW TO COMPLETE PROCEDURE WITH NO FURTHER PROBLEM. NO PIECES BROKE INTO WOUND AND THERE WAS NOTHING TO RETRIEVE. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185629 HELICAL BLADE COUPLING SCREW LXH SYNTHES BRANDYWINE 5194962

    Patients

    Seq Age Sex Outcome Treatment
    1