BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARROLL-GIRARD SCREW HEX-END

    MDR report key: 7172312 · Received January 8, 2018

    Report

    Report Number
    0001032347-2018-00015
    Event Type
    Injury
    Date Received
    January 8, 2018
    Date of Event
    November 1, 2017
    Report Date
    June 29, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWI
    PMA / PMN Number
    PN/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE PRODUCT WAS VISUALLY EVALUATED AND WAS SEEN TO BE FRACTURED. THERE IS NO TISSUE REMAINING IN THE THREADS. THERE ARE NO SIGNS OF MANUFACTURING DEFECTS. THE MOST LIKELY CAUSE OF THIS IS EXCESSIVE FORCE ON AN OFF AXIS ANGLE WHILE ATTEMPTING TO APPROXIMATE TIGHTLY POSITIONED BONE FRAGMENTS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO EXCESSIVE FORCE AT AN OFF AXIS ANGLE. INSTRUCTIONS FOR USE (IFU)STATES: AVOID UNDUE STRESS OR STRAIN WHEN HANDLING OR CLEANING INSTRUMENTS. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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. THE FOLLOWING WAS CORRECTED: DEVICE MANUFACTURE DATE WAS CORRECTED FROM NOV 18, 2014 TO OCT 20, 2014.

    Additional Manufacturer Narrative · 1

    (B)(4). (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 "THE SCREW FRACTURED DURING ZYGOMATIC FRACTURE REDUCTION. THE TIP OF THE REMAINED SCREW IN THE PATIENT¿S BONE WAS REMOVED USING OTHER DEVICE. THE SURGERY WAS COMPLETED USING A U TYPE HOOK AND THE DELAY WAS LESS THAN 20 MINUTES." THE FOLLOWING CONTRIBUTING FACTOR RELATED TO THE EVENT WAS REPORTED, "THE SURGEON PULLED A SCREW OBLIQUELY IN THE STRONG FORCE DURING PROCEDURE." NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14691 CARROLL-GIRARD SCREW HEX-END CORKSCREW HWI BIOMET MICROFIXATION N/A 566220

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention