BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HELIX BLADE 85MM

    MDR report key: 3221033 · Received July 11, 2013

    Report

    Report Number
    2520274-2013-04310
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 24, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    JDO
    PMA / PMN Number
    K981757
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE WAS RETURNED FOR EVALUATION. A MANUFACTURING EVALUATION WAS CONDUCTED. THE REPORT INDICATES PART WAS RECEIVED LOCKED INTO A DHS PLATE. THE BLADE COULD NOT BE REMOVED FROM THE PLATE DUE TO THE FACT THAT THE BLADE WAS INSERTED INCORRECTLY AND IS THEREFORE JAMMED INTO THE PLATE. THE LOT NUMBER IS UNAVAILABLE SINCE THAT PORTION IS CONTAINED WITHIN THE DHS PLATE. THE APPEARANCE OF THE BLADE IS AS NEW; IT DOES NOT APPEAR TO HAVE BEEN USED. THE BLADE IS JAMMED, NO MEASUREMENTS CAN BE TAKEN. A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED AND THE REPORT INDICATES THE PROBABLE CAUSE OF THIS COMPLAINT IS FAILURE TO FOLLOW PROPER TECHNIQUE. STEP 6 ON THE TECHNIQUE GUIDE PROVIDES DETAIL INSTRUCTIONS ON USING THE ALIGNMENT SHAFT (338.342) TO ALIGN THE KEY OF THE SIDE PLATE WITH THE HELICAL BLADE SHAFT. IF THIS STEP IS NOT FOLLOWED THE KEY OF THE SIDE PLATE WOULD NOT ALIGN AND COULD JAM WITH THE SHAFT OF THE HELICAL BLADE WHEN THE PATIENT WEIGHT BEARING ON THE DEVICE. THE SIDE PLATE AND HELICAL BLADE DESIGNS WERE REVIEWED AND DETERMINED TO MEET THE INTENDED USE. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN WHEN THE PATIENT STARTED TO FEEL THE PAIN. THEREFORE, THE EVENT DATE IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUFFERED A RIGHT INTERTROCHANTERIC (IT) FRACTURE, SUBTROCHANTERIC FRACTURE IN MARCH. SURGERY WAS PERFORMED WITH A DYNAMIC HELICAL HIP SYSTEM SIDE PLATE AND HELICAL HIP SCREW. IT WAS REPORTED THAT THE HELICAL BLADE HAD MIGRATED INTO THE ACETABULUM OF THE PATIENT AND NEEDED TO BE REMOVED. SURGERY WAS PLANNED FOR (B)(6) 2013. THE ENTIRE CONSTRUCT WAS VERY EASILY REMOVED AND RE-IMPLANTED A 4.5MM LOCKING COMPRESSION PROXIMAL FEMUR PLATE. THE PATIENT HAD PAIN FROM IMPLANT FAILURE. REVISION SURGERY WENT WELL AND THE SURGEON WAS HAPPY WITH THE NEW IMPLANT PLACEMENT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320548 HELIX BLADE 85MM JDO SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention