BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LSB STYLE ANCHOR BOLTS

    MDR report key: 8748079 · Received July 1, 2019

    Report

    Report Number
    2183456-2019-00005
    Event Type
    Injury
    Date Received
    July 1, 2019
    Report Date
    June 21, 2019
    Manufacturer
    AD-TECH MEDICAL INSTRUMENT CORP.
    Product Code
    GZL
    PMA / PMN Number
    K163355
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AS STATED IN THE EVENT DESCRIPTION ON JUNE 12, 2019 INFORMATION WAS BROUGHT TO THE AD-TECH MEDICAL INSTRUMENT CORPORATION REGULATORY TEAM IN REGARDS TO THE POSSIBILITY OF ANCHOR BOLTS BEING DISTRIBUTED NON-STERILE AND STERILIZED AT THE SITE VIA STERRAD STERILIZATION. IT WAS STATED THAT THREE DIFFERENT OCCASIONS BETWEEN (B)(6) 2019 AND (B)(6) 2019 AD-TECH PERSONNEL HAVE DISTRIBUTED NON-STERILE ANCHOR BOLT PARTS TO ONE INDEPENDENT REPRESENTATIVE AND ONE INTERNATIONAL DISTRIBUTOR, WHO MAY HAVE SUBSEQUENTLY STERILIZED THE NON-STERILE ANCHOR BOLTS FOR CLINICAL USE. AD-TECH DOES NOT HAVE REGULATORY CLEARANCE TO DISTRIBUTE NON-STERILE ANCHOR BOLTS AND DOES NOT HAVE A VALIDATED HOSPITAL STERILIZATION METHOD FOR THESE DEVICES. FURTHER, AD-TECH LABELING DOES NOT INCLUDE INSTRUCTIONS FOR STERILIZING ANCHOR BOLTS AS AD-TECH STERILIZES THE ANCHOR BOLTS VIA ETHYLENE OXIDE (ETO) STERILIZATION PRIOR TO DISTRIBUTION. AD-TECH ALSO RECEIVED A PICTURE OF AN AD-TECH LSB STYLE ANCHOR BOLT IN A STERRAD POUCH IN AN OPERATING ROOM. A RECALL IS BEING INITIATED FOR THIS ISSUE.

    Description of Event or Problem · 1

    ON JUNE 12, 2019 AD-TECH WAS MADE AWARE THAT ON 3 DIFFERENT OCCASIONS BETWEEN (B)(6) 2019 AND (B)(6) 2019 AD-TECH PERSONNEL HAD DISTRIBUTED NON-STERILE ANCHOR BOLT PARTS TO ONE INDEPENDENT REPRESENTATIVE AND ONE INTERNATIONAL DISTRIBUTOR, WHO MAY HAVE SUBSEQUENTLY STERILIZED THE NON-STERILE ANCHOR BOLTS FOR CLINICAL USE. AD-TECH DOES NOT HAVE REGULATORY CLEARANCE TO DISTRIBUTE NON-STERILE ANCHOR BOLTS AND DOES NOT HAVE A VALIDATED HOSPITAL STERILIZATION METHOD FOR THESE DEVICES. FURTHER, AD-TECH LABELING DOES NOT INCLUDE INSTRUCTIONS FOR STERILIZING ANCHOR BOLTS AS AD-TECH STERILIZES THE ANCHOR BOLTS VIA ETHYLENE OXIDE (ETO) STERILIZATION PRIOR TO DISTRIBUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540650 LSB STYLE ANCHOR BOLTS ANCHOR BOLT GZL AD-TECH MEDICAL INSTRUMENT CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other