BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HELICAL BLADE COUPLING SCREW

    MDR report key: 3070707 · Received April 22, 2013

    Report

    Report Number
    2530088-2013-10460
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    August 25, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. 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. IT WAS INITIALLY REPORTED THAT THE DEVICE WAS NOT EVALUATED THIS INFORMATION WAS INCORRECT. A PRODUCT EVALUATION WAS PERFORMED WHICH REVEALED THE FOLLOWING: THERE IS NO ISSUE WITH THE RETURNED HELICAL BLADE INSERTER. ALL THE PARTS ARE INTACT, THE DEVICE FUNCTIONS AS DESIGNED, AND IT CAN BE ASSEMBLED AND DISASSEMBLED AS INTENDED. THE VISUAL INSPECTION REVEALED THE HELICAL BLADE COUPLING SCREW WAS RECEIVED WITH THE HEAD BROKEN OFF. AS NOTED IN PRIOR COMPLAINTS, THE HELICAL BLADE COUPLING SCREW IS HAMMERED REPEATEDLY AS PART OF THE TECHNIQUE TO INSERT THE HELICAL BLADE. 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 (J3900-G), COULD RESULT IN LOADING CONDITIONS THAT MAY LEAD TO BREAKAGE. THE RETURNED DEVICE WAS MANUFACTURED IN MAY 2003 AND IS OVER 8 YEARS OLD AND SHOWS EVIDENCE OF BEING USED AND HAMMERED EXTENSIVELY OVER THAT TIME. THE DENTS AROUND THE PERIMETER OF THE HEAD INDICATE THAT IT HAS BEEN STRUCK OFF-ANGLE NUMEROUS TIMES. THERE WAS NO ISSUE WITH THE HELICAL BLADE INSERTER AND THE DESIGN OF THE HELICAL BLADE COUPLING SCREW WAS REVIEWED AND DETERMINED TO BE ACCEPTABLE FOR THE INTENDED USE AND THEREFORE THE COMPLAINT IS INVALID WITH RESPECT TO DESIGN. PLACEHOLDER.

    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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE DEVICE WAS RECEIVED, HOWEVER, NO EVALUATION IS AVAILABLE.

    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. AVAILABLE INFORMATION IN THE COMPLAINT FILE INDICATES THAT THE DEVICE IN QUESTION WAS RETURNED TO SYNTHES; HOWEVER, THE MDR REPORTABILITY STATUS AT THE TIME OF THE DEVICE RETURN WAS NOT-REPORTABLE. NO EVALUATION OF THE PRODUCT WAS REQUIRED FOR MDR NON-REPORTABLE COMPLAINTS PER THE COMPLAINT INVESTIGATION PROCEDURE AT THE TIME OF THE PRODUCT RECEIPT AND COMPLAINT INVESTIGATION. THIS FILE WAS REVIEWED UNDER PROTOCOL 2013-3000 FOR MDR REMEDIATION AND THE MDR REPORTABILITY DECISION WAS REVISED TO MDR REPORTABLE. THE PRODUCT IS NO LONGER AVAILABLE FOR ANALYSIS. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. ORIGINAL AWARENESS DATE IS (B)(4) 2011. PLACEHOLDER.

    Description of Event or Problem · 1

    PROCEDURE WAS REPORTED AS TROCHANTERIC FIXATION NAIL (TFN) OF THE FEMUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TFN PROCEDURE OF THE FEMUR, THE SURGEON WAS INSERTING THE HELICAL BLADE WITH THE HELICAL BLADE INSERTER. THE COUPLING SCREW ON THE END OF THE INSERTER SHEARED OFF AND THE BROKEN PIECE FELL TO THE FLOOR. THE SURGEON USED A T-HANDLE CHUCK WITH A DRILL BIT ATTACHED TO IT TO BE ABLE TO REMOVE THE HELICAL BLADE INSERTER AND THE REMAINDER OF THE COUPLING SCREW. THE HELICAL BLADE REMAINED IN PLACE AS NEEDED FOR THE PROCEDURE, AND THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE. APPROXIMATELY 25 MINUTES WERE ADDED TO THE CASE TO REMOVE THE INSERTER AND BROKEN COUPLING SCREW. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171664 HELICAL BLADE COUPLING SCREW LXH SYNTHES BRANDYWINE 4566328

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention