BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 105MM

    MDR report key: 2923621 · Received January 22, 2013

    Report

    Report Number
    3003506883-2013-00035
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 25, 2012
    Report Date
    December 25, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO ANOMALIES NOTED.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS CONDUCTED AND IT STATES THAT THE RECEIVED CONDITION OF THE HELIX BLADE SHOWS ANODIZED RUBBED AWAY ON THE SHAFT. SOME MATERIAL DISPLACEMENT AND DAMAGE IS EVIDENT IN THE POCKET FEATURE. THE DAMAGE TO THE POCKET FEATURE PREVENTS MEASUREMENT OF W4. SINCE FEATURES RELEVANT TO THE COMPLAINT CONDITION CANNOT BE MEASURED, THE COMPLAINT IS INDETERMINATE. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE LOCKING MECHANISM TAB HAS SHEARED OFF AND THE REMAINING PORTION IS BENT INWARD. DURING THIS EVALUATION, THE RETURNED DEVICES WERE ASSEMBLED WITH KNOWN GOOD MATING INSTRUMENTS AND IMPLANTS TO COMPLETE THE INSERTION CONSTRUCT IN ORDER TO EVALUATE THE ALIGNMENT OF THE RETURNED DEVICES. THE CONSTRUCT ASSEMBLED AND THE RETURNED HELICAL BLADE ALIGNED AND ENTERED THE RETURNED TFN AS INTENDED BUT MET RESISTANCE WITH THE DAMAGED/BENT LOCKING MECHANISM. THE COMPLAINT CONDITION WAS REPLICATED. THE RISK ANALYSIS ADEQUATELY ADDRESSES THIS COMPLAINT CONDITION AS LESS SEVERE WITH A MODERATE SEVERITY OF HARM 3 AND AN IMPROBABLE PROBABILITY OF OCCURRENCE 1. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. IT CAN NOT BE DEFINITIVELY DETERMINED HOW OR WHEN THE LOCKING MECHANISM WAS DEPLOYED.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    DURING SURGERY FOR A TFN NAILING PROCEDURE ON (B)(6) 2012, THE HELICAL BLADE WOULD NOT ADVANCE THROUGH THE NAIL. THE SURGEON DETERMINED THE LOCKING MECHANISM HAD BEEN DEPLOYED. THE SURGEON REMOVED THE BLADE AND TRIED TO BACK OUT THE LOCKING MECHANISM IN THE NAIL BUT WAS UNABLE TO DO SO BECAUSE THE LOCKING TAB HAD BEEN DAMAGED AND BENT WHILE TRYING TO INSERT THE BLADE. THE NAIL WAS REMOVED AND REPLACED WITH A NEW NAIL AND HELICAL BLADE WITH NO FURTHER PROBLEMS. IT WAS NOTED THAT ALL PARTS OF THE ORIGINAL NAIL WERE INTACT AND THEREFORE, THERE WERE NO FRAGMENTS TO RETRIEVE. THE PROCEDURE WAS EXTENDED BY APPROXIMATELY 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29564 11.0MM TI HELICAL BLADE 105MM HELICAL BLADE HSB SYNTHES ELMIRA 6999970

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention TROCH FIXATION NAIL