BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5 MM CORTICAL SCREW SELF-TAPPING 24 MM LENGTH

    MDR report key: 8464531 · Received March 29, 2019

    Report

    Report Number
    0001822565-2019-01344
    Event Type
    Injury
    Date Received
    March 29, 2019
    Date of Event
    March 1, 2019
    Report Date
    May 30, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWC
    PMA / PMN Number
    K143066
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: FRACTURE OF THE MOST DISTAL SCREW OF THE PROXIMAL HUMERAL PLATE AND SCREW FIXATION, WITH LATERAL DISPLACEMENT OF THE LATE AND ABNORMAL ALIGNMENT AT THE MEDIAL FRACTURE LINE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 0001822565-2019-013441. REPORT SOURCE: (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE EVALUATED BY MFR: PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION DUE TO IMPLANT FRACTURE. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259499 3.5 MM CORTICAL SCREW SELF-TAPPING 24 MM LENGTH SCREW, FIXATION HWC ZIMMER BIOMET, INC. 62414575

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention