BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4221086 · Received November 3, 2014

    Report

    Report Number
    2520274-2014-14286
    Event Type
    Injury
    Date Received
    November 3, 2014
    Report Date
    October 15, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ¿HOOK LEVERAGE TECHNIQUE FOR REDUCTION OF INTERTROCHANTERIC FRACTURE¿ (2014). KIM, Y., AND ET. AL. INJURY. INTERNATIONAL JOURNAL OF THE CARE OF THE INJURED, 45: 1006-1010. 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, ¿HOOK LEVERAGE TECHNIQUE FOR REDUCTION OF INTERTROCHANTERIC FRACTURE¿ (2014). KIM, Y., AND ET. AL. INJURY. INTERNATIONAL JOURNAL OF THE CARE OF THE INJURED, 45: 1006-1010. THE AUTHORS RETROSPECTIVELY COLLECTED 8 OF 78 CASES OF INTERTROCHANTERIC FRACTURE REDUCED BY PERCUTANEOUS REDUCTION AND TREATED WITH INTRAMEDULLARY NAIL FIXATION BETWEEN FEBRUARY 2010 AND JUNE 2013. THERE WERE 3 MALE AND 5 FEMALE PATIENTS WITH AN AVERAGE AGE OF 77.9 (RANGE 47¿89) YEARS. THE FRACTURES WERE FIXED USING THE PFNA DEVICE (SYNTHES (B)(4)). IN THREE CASES, IN WHICH THEY MANAGED GOOD REDUCTIONS USING THEIR TECHNIQUE, THERE WAS A LOSS OF REDUCTION DURING THE NAIL INSERTION, AND EVEN AFTER FURTHER REDUCTION MANIPULATIONS. IN ONE CASE, RADIOGRAPHS SHOWED CUT-OUT OF HELICAL BLADE, CAUSED BY UNACCEPTABLE ANTEROMEDIAL CORTEX REDUCTION GREATER THAN 1 YEAR AFTER SURGERY. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN HELICAL BLADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703141 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention