BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN 4MM CANNULATED ASNIS TITANIUM SCREW

    MDR report key: 13999650 · Received April 4, 2022

    Report

    Report Number
    0008031020-2022-00139
    Event Type
    Injury
    Date Received
    April 4, 2022
    Date of Event
    January 31, 2017
    Report Date
    April 4, 2022
    Manufacturer
    STRYKER GMBH
    Product Code
    HWC
    PMA / PMN Number
    K000080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. LITERATURE.

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY DEPARTMENT OF TRAUMA AND ORTHOPEDIC SURGERY, SECTION FOR RECONSTRUCTIVE AND HAND SURGERY, FEDERAL ARMED FORCES HOSPITAL WESTERSTEDE, GERMANY. THE TITLE OF THIS REPORT IS ¿MODIFIED MINIMALLY INVASIVE EXTENSOR CARPI RADIALIS LONGUS TENODESIS FOR SCAPHOLUNATE DISSOCIATION: A PROSPECTIVE OBSERVATIONAL STUDY¿ PUBLISHED ON JANUARY 31, 2017, WHICH IS ASSOCIATED WITH THE STRYKER ¿ASNIS III CANNULATED SCREW¿ SYSTEM. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.1186/S12891-017-1414-7. THIS REPORT INCLUDES ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 54 PATIENTS, AND THE CASES IN THIS STUDY RANGE FROM SEPTEMBER 2008 TO JUNE 2012. DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH SPECIFIC DEVICE DETAILS, PATIENT INFORMATION, AND AT THIS TIME NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE. IT WAS REPORTED THAT 1 PATIENT EXPERIENCED SCREW FAILURE. THE REPORT STATES, ¿DEVELOPMENT OF A NEUROMA, SCREW FAILURE, AS WELL AS COMPLEX REGIONAL PAIN SYNDROME WAS REPORTED IN ONE PATIENT EACH (2.2%). NONE OF THE PATIENTS REPORTED A RECURRENCE OF SYMPTOMS.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066928 UNKNOWN 4MM CANNULATED ASNIS TITANIUM SCREW SCREW, FIXATION, BONE HWC STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention