BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    UNKNOWN 4MM CANNULATED ASNIS TITANIUM SCREW

    MDR report key: 13999217 · Received April 4, 2022

    Report

    Report Number
    0008031020-2022-00138
    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
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF EVENTS SUMMARIZED AS PART OF LITERATURE REVIEW, WHEN DEVICE AND PATIENT INFORMATION IS NOT AVAILABLE. THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS DISCOVERED DURING POST MARKET SURVEILLANCE LITERATURE REVIEW. THE ALLEGED SCREW-IMPINGEMENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR. MORE DETAILED INFORMATION ABOUT THE PATIENT MEDICAL HISTORY, THE EVENT CIRCUMSTANCES, RADIOGRAPHS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.

    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 RADIAL IS 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 20 PATIENTS EXPERIENCED SCREW-IMPINGEMENT, WHICH WAS OPTIONALLY TREATED WITH REMOVAL OF THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264720 UNKNOWN 4MM CANNULATED ASNIS TITANIUM SCREW SCREW, FIXATION, BONE HWC STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention