BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 105MM-STERILE

    MDR report key: 2993975 · Received March 8, 2013

    Report

    Report Number
    3003506883-2013-10057
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    November 30, 2011
    Report Date
    November 30, 2011
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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. THE PRODUCT DEVELOPMENT EVENT EVALUATION REVEALED BASED ON EXAMINATION OF THE RETURNED PARTS, THE LOCKING MECHANISM WAS IN THE LOCKED POSITION WHEN ATTEMPTING TO INSERT THE HELICAL BLADE AND THE LOCKING TAB WAS BROKEN OFF AS A RESULT. THE INSTRUMENTS WERE DAMAGED FROM TRYING TO FORCE THE BLADE THROUGH THE NAIL WITH THE LOCKING MECHANISM IN THE WAY AND THEN REMOVING IT ONCE IT WAS STUCK. THIS COMPLAINT IS VALID FOR THE NAIL (LOCKING MECHANISM IN THE NAIL BEING IN THE LOCKED POSITION) AND INVALID FOR THE BLADE AND INSTRUMENTS. IT IS CONCLUDED THIS COMPLAINT IS VALID FOR THE NAIL WITH THE LOCKING MECHANISM IN THE LOCKED POSITION PRIOR TO INSERTING THE HELICAL BLADE AND INVALID FOR THE HELICAL BLADE AND INSTRUMENTS. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    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 PRODUCT CODES: HSB. MANUFACTURING INVESTIGATION REVEALED THAT THE PRODUCT MET THE LATEST DESIGN SPECIFICATIONS. THE DAMAGE TO THE POCKET FEATURE PREVENTED MEASUREMENTS OF THE FLUTE CUTTING EDGE. SINCE ALL FEATURES RELEVANT TO THE COMPLAINT CONDITION CANNOT BE MEASURED, THE COMPLAINT IS INDETERMINATE. CORRECTED INFORMATION: ORIGINAL AWARENESS DATE IS (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE, THE SURGEON INSERTED THE NAIL, THEN INSERTED THE BLADE THROUGH THE NAIL, AND THE BLADE GOT STUCK AND WOULD NOT ADVANCE. THE SURGEON TRIED MALLETING THE BLADE BUT IT WOULD NOT ADVANCE. X-RAY CONFIRMED THAT THE LOCKING MECHANISM WAS IN DOWN POSITION. SURGEON BACKED LOCKING MECHANISM OUT WITH SCREWDRIVER. SURGEON HAD TO USE EXCESSIVE FORCE TO REMOVE THE BLADE WHICH WAS EMBEDDED IN THE NAIL. THE INSERTER AND CONNECTING SCREW WERE DAMAGED DURING THE REMOVAL OF THE BLADE FROM THE NAIL. SURGEON SELECTED ANOTHER NAIL, WHICH WAS SHORTER AND A NEW HELICAL BLADE TO COMPLETE PROCEDURE WITH NO FURTHER PROBLEM. PROCEDURE WAS EXTENDED BY APPROXIMATELY ONE HOUR. THIS IS REPORT 2 OF 4 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98695 11.0MM TI HELICAL BLADE 105MM-STERILE HSB SYNTHES ELMIRA 6770690

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention