BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 90MM

    MDR report key: 3242404 · Received July 23, 2013

    Report

    Report Number
    3003506883-2013-00312
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 2, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS FOR TREATMENT, NOT DIAGNOSIS. PART RECEIVED INTACT. THERE IS A SMALL AREA AT THE BEGINNING OF THE SHAFT WHERE THE ANODIZE COLOR IS RUBBED OFF. ONE OF THE FLUTE TIPS EXHIBITS A DENT APPROXIMATELY 1MM DEEP MOST LIKELY CAUSED BY HITTING THE EDGE OF THE NAIL WITH THE BLADE DURING ATTEMPTED INSERTION. ALL MEASUREMENTS ARE WITHIN STATED MANUFACTURING TOLERANCES. THE DAMAGE SEEN ON THE BLADE WAS NOT CAUSED DURING MANUFACTURE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH ONE NONCONFORMANCE NOTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE CONSTRUCT PROPERLY ADJUSTED PER THE TECHNIQUE GUIDE (J2900-1), THE MISALIGNED CONDITION COULD NOT BE REPLICATED. THE DESIGN IS DETERMINED TO BE ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    DURING A TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE, FOUR HELICAL BLADES WOULD NOT INSERT INTO TWO DIFFERENT NAILS. ATTEMPTS TO USE K-WIRES, REDRILLING, AND VARIOUS BLADE SIZES YIELDED NO ATTACHMENT. SURGEON DECIDED TO CHANGE TO A 11X380 FROM A 12X380 FIXATION NAIL AFTER THREE HELICAL BLADES OF DIFFERENT SIZES WERE NOT ACCEPTED. SURGEON TESTED THE FOURTH HELICAL BLADE ON THE TABLE WITH 11X380 NAIL PRIOR TO INSERTION. A11X380 FIXATION NAIL DID NOT ACCEPT FOURTH HELICAL BLADE. A FIFTH BLADE WAS ACCEPTED WITH ONE OF THE NAILS THAT DID NOT FIT WITH A PREVIOUS BLADE. REPORTEDLY, THE FOUR PREVIOUSLY USED BLADES WERE ALL DINGED IN THE SAME LOCATION AFTER ATTEMPTED PLACEMENT, IN SPITE OF BEING VARIOUS SIZES. THE SURGERY WAS DELAYED APPROXIMATELY 2.5 HOURS AS A RESULT OF THIS EVENT. THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344217 11.0MM TI HELICAL BLADE 90MM HSB SYNTHES ELMIRA 7066264

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention