BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GAMMA3 LONG NAIL CASE 3

    MDR report key: 11443442 · Received March 9, 2021

    Report

    Report Number
    0009610622-2021-00337
    Event Type
    Injury
    Date Received
    March 9, 2021
    Date of Event
    August 25, 2015
    Report Date
    March 9, 2021
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION IS AVAILABLE. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE AFFECTED LOT NUMBER WAS NOT COMMUNICATED. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED. DEVICE DISPOSITION IS UNKNOWN

    Description of Event or Problem · 1

    THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY DEPARTMENT OF ORTHOPAEDICS AND TRAUMATOLOGY, HOSPITAL (B)(6) IN (B)(6). THE TITLE OF THIS REPORT IS ¿CEPHALOMEDULLARY NAILS: FACTORS ASSOCIATED WITH IMPINGEMENT OF THE ANTERIOR CORTEX OF THE FEMUR IN A HISPANIC POPULATION¿ PUBLISHED ON AUGUST 25, 2015, WHICH IS ASSOCIATED WITH THE STRYKER ¿GAMMA3 NAILING¿ SYSTEM. THE ARTICLE CAN BE FOUND DOI 10.1007/S00402-015-2313-8. THIS REPORT INCLUDES RESEARCH DONE ON 67 PATIENTS BETWEEN THE PERIOD 2010 AND 2013. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE DETAILS OR PATIENT INFORMATION FROM THE REPORT, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, NEW COMPLAINTS WERE INITIATED IN THE SYSTEM FOR THE POST-OPERATIVE COMPLICATIONS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES (3) CASES OF PENETRATION OF THE ANTERIOR CORTEX OF THE FEMUR. THE REPORT STATES THREE OF THE PATIENTS WITH PERFORATION DID NOT REQUIRE ADDITIONAL PROCEDURES DUE TO SLIGHT ELEVATION OF THE ANTERIOR CORTEX, THE REASON WHY WEIGHT-BEARING WAS RESTRICTED DURING THE POSTOPERATIVE PERIOD BASED ON THE SURGEON CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342347 UNKNOWN GAMMA3 LONG NAIL CASE 3 IMPLANT HSB STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other