BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 3813128 · Received May 15, 2014

    Report

    Report Number
    2520274-2014-11314
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 22, 2014
    Manufacturer
    DEPUY SYNTHES
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: OH, J.K., HWANG, J.H., LEE, S.J., KIM, J. II DYNAMIZATION OF LOCKED PLATING ON DISTAL FEMUR FRACTURE. ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY (2011) 131:535-539. THE ARTICLE REPORTS A (B)(6) FEMALE WITH OSTEOARTHRITIS EXPERIENCED A NONUNION AFTER MIPO (MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS) FOR A LONG OBLIQUE FRACTURE OF THE DISTAL FEMUR. A SEVEN-HOLE LCP-DF PLATE (SYNTHES US) WAS USED. A CORTICAL 4.5 MM SCREW WAS PLACED ACROSS FRACTURE SITE AS A REDUCTION SCREW TO REDUCE THE DISTAL FRAGMENT THROUGH THE DYNAMIC COMPRESSION UNIT OF A COMBINATION HOLE OF THE LOCKING COMPRESSION PLATE-DISTAL FEMUR. AT THIS TIME, THE NEAR CORTEX WAS OVER-DRILLED WITH A 4.5 MM DRILL BIT. POSTOPERATIVE RADIOGRAPHS SHOWED GOOD ALIGNMENT EXCEPT SMALL DEGREE OF ANTERIOR ANGULATION ON THE LATERAL VIEW. NO POST-OPERATIVE COMPLICATIONS WERE REPORTED. AFTER SIX MONTHS, RADIOGRAPHS FAILED TO SHOW ANY CALLUS FORMATION AND COMPUTED TOMOGRAPHY (CT) SCANS REVEALED A FRACTURE GAP. AUTHOR REPORTS THE CORTICAL SCREW ACTED LIKE A LAG SCREW AND MADE THE CONSTRUCT TOO STIFF WHICH CAUSED THE NONUNION. LAG SCREW WAS REMOVED TO ALLOW MOTION AT THE FRACTURE SITE. SIX MONTHS LATER RADIOGRAPHS SHOWED SOLID FRACTURE HEALING WITH BRIDGING CALLUS FORMATION ALONG THE MEDICAL CORTEX. THIS ARTICLE SUMMARIZES POSTOPERATIVE FINDINGS FROM OTHER PUBLISHED ARTICLES. THIS IS 1 OF 2 REPORTS FOR COMPLAINT - (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290886 SCREW HWC DEPUY SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention