BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CABLE READY SYSTEM

    MDR report key: 7235237 · Received February 1, 2018

    Report

    Report Number
    0001822565-2018-00482
    Event Type
    Injury
    Date Received
    February 1, 2018
    Report Date
    January 22, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HTN
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOREIGN. THE EVENT OCCURRED IN (B)(6). LITERATURE: HAN, K., LEE, D., & BANG, J. (2017). DO CERCLAGE CABLES DELAY THE TIME TO BONE UNION IN PATIENTS WITH AN UNSTABLE HUMERAL SHAFT FRACTURE TREATED WITH INTRAMEDULLARY NAILS? YONSEI MEDICAL JOURNAL, 58(4), 837. DOI:10.3349/YMJ.2017.58.4.837. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO 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. - (B)(4). NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE JOURNAL ARTICLE, ONE PATIENT EXPERIENCED RADIAL NERVE PALSY FOLLOWING TREATMENT FOR HUMERAL SHAFT FRACTURE. THE PATIENT WAS REPORTED TO HAVE IMPROVED WITHIN 6 MONTHS POST-OPERATION. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77474 UNKNOWN CABLE READY SYSTEM WASHER, BOLT NUT HTN ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other