BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, FIXATION, INTRAMEDULLARY

    MDR report key: 4229862 · Received November 6, 2014

    Report

    Report Number
    2520274-2014-14290
    Event Type
    Injury
    Date Received
    November 6, 2014
    Report Date
    October 17, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. CHUN, Y., OH, H., CHO, Y. AND RHYU, K. (2011), TECHNIQUE AND EARLY RESULTS OF PERCUTANEOUS REDUCTION OF SAGITTALLY UNSTABLE INTERTROCHANTERIC FRACTURES. CLINICS IN ORTHOPEDIC SURGERY, 3, 217-224. THIS REPORT IS FOR AN UNKNOWN HELICAL BLADE/UNKNOWN QUANTITY/UNKNOWN LOT. (B)(4). THE 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: CHUN, Y., OH, H., CHO, Y. AND RHYU, K. (2011), TECHNIQUE AND EARLY RESULTS OF PERCUTANEOUS REDUCTION OF SAGITTALLY UNSTABLE INTERTROCHANTERIC FRACTURES. CLINICS IN ORTHOPEDIC SURGERY, 3, 217-224. THE AUTHORS CONDUCTED A STUDY TO COMPARE A PERCUTANEOUS REDUCTION TECHNIQUE USING ONE OR TWO STEINMAN PINS TO REDUCE SAGITTALLY UNSTABLE INTERTROCHANTERIC FRACTURES VERSUS A CONTROL GROUP. SAGITTAL DISPLACEMENT WAS STABILIZED WITH SYNTHES DEVICE, PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA). ONE HUNDRED NINETEEN INTERTROCHANTERIC FRACTURES IN 115 PATIENTS AGED 65 YEARS OR OLDER WERE TREATED FROM JUNE 2007 TO DECEMBER 2008. OF THEM, 21 HIPS IN 20 PATIENTS SHOWED SAGITTAL INSTABILITY (STUDY GROUP); NINETEEN HIPS WERE FOLLOWED UP FOR MORE THAN ONE YEAR. CLINICAL AND RADIOLOGICAL RESULTS OF THE STUDY GROUP WERE REVIEWED AND COMPARED WITH THOSE OF THE REMAINING CASES WHO DID NOT SHOW SAGITTAL INSTABILITY (CONTROL GROUP). RESULTS INCLUDED TWO HIPS WITH CUTOUT IN THE CONTROL GROUP; THESE TWO DID NOT ACHIEVE UNION. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN HELICAL BLADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712592 ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention