BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIBFIX BLU SYSTEM TEMPORARY FIXATION SCREW

    MDR report key: 7748865 · Received August 3, 2018

    Report

    Report Number
    0001032347-2018-00521
    Event Type
    Injury
    Date Received
    August 3, 2018
    Date of Event
    June 21, 2018
    Report Date
    November 26, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK142823
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE TEMPORARY FIXATION SCREW (PART# 76-0007, LOT# 225160) WAS VISUALLY EVALUATED. THE SCREW SHOWED SIGNS OF WEAR, WITH SCRATCHES ALONG THE BODY AND SOME DISCOLORATION. THE FLUTED SECTION OF THE SCREW WAS ALSO FRACTURED OFF. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO EXCESSIVE FORCE APPLIED DURING INSERTION. THE INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT STATES IN THE SECTION TITLED WARNINGS: INTRAOPERATIVE FRACTURE OF SCREWS CAN OCCUR IF EXCESSIVE FORCE (TORQUE) IS APPLIED WHILE SEATING BONE SCREWS. THE IFU ALSO STATES IN THE SECTION TITLED BONE SCREWS: EXCESSIVE TORQUE CAN CAUSE THE SCREW TO FRACTURE. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: FOREIGN COUNTRY - (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A STERNAL FIXATION PROCEDURE THE TIP OF THE TEMPORARY FIXATION SCREW BROKE OFF, AND REMAIN IN THE PATIENT¿S STERNUM. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590778 RIBFIX BLU SYSTEM TEMPORARY FIXATION SCREW TEMPORARY FIXATION SCREW HRS BIOMET MICROFIXATION N/A 225160

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability