BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 6534922 · Received May 1, 2017

    Report

    Report Number
    2520274-2017-11554
    Event Type
    Injury
    Date Received
    May 1, 2017
    Report Date
    April 5, 2017
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. YOO, J.H., KIM, S.W., KWAK, Y.H., AND KIM, H.J. (2015) OVERLAPPING INTRAMEDULLARY NAILING AFTER FAILED MINIMALLY INVASIVE LOCKED PLATING FOR OSTEOPOROTIC DISTAL FEMUR FRACTURES - REPORT OF 2 CASES. INJURY, INT. J. CARE INJURED 46;1174-1177. SOUTH KOREA. THIS IS FOR UNKNOWN PROXIMAL LOCKING SCREW/UNKNOWN PART NUMBER/UNKNOWN LOT. (UDI): UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. THE SUBJECT DEVICE IS NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. (B)(4). 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

    LITERATURE ARTICLE RECEIVED. THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: YOO, J.H., KIM, S.W., KWAK, Y.H., AND KIM, H.J. (2015) OVERLAPPING INTRAMEDULLARY NAILING AFTER FAILED MINIMALLY INVASIVE LOCKED PLATING FOR OSTEOPOROTIC DISTAL FEMUR FRACTURES - REPORT OF 2 CASES. INJURY, INT. J. CARE INJURED 46;1174-1177. SOUTH KOREA. A (B)(6) FEMALE PATIENT SUSTAINED A CLOSED DISTAL FEMUR FRACTURE DUE TO A GROUND-LEVEL FALL AND UNDERWENT CLOSED REDUCTION AND (MIPO) MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS WITH A 7-HOLE LCP (DEPUY SYNTHES, (B)(4)). THE PATIENT WAS RELATIVELY OBESE WITH A BODY MASS INDEX (B)(6) AND HAD REGULARLY TAKEN AN ANTI-OSTEOPOROTIC DRUG FOR 2 YEARS. ONE MONTH AFTER THE OPERATION THE PATIENT SUSTAINED IMPLANT FAILURE WITH BREAKAGE OR PULL-OUT OF 4 PROXIMAL LOCKING SCREWS AND SUBSEQUENT FRACTURE. THE IMPLANT FAILURE WAS CAUSED BY INSUFFICIENT FIXATION OF PROXIMAL FRAGMENT SECONDARY TO THE USE OF SHORT PLATE AND UNICORTICAL LOCKING SCREW IN OSTEOPOROTIC BONE. IM NAILING WITH PLATE AND DISTAL SCREWS LEFT IN SITU WAS PERFORMED. THIS REPORT IS FOR FOUR (4) UNKNOWN PROXIMAL LOCKING SCREWS. THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315072 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention