BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5 LACTOSORB SYSTEM 1.5 X 5 MM LACTOSORB SCREW

    MDR report key: 7331360 · Received March 12, 2018

    Report

    Report Number
    0001032347-2018-00120
    Event Type
    Malfunction
    Date Received
    March 12, 2018
    Date of Event
    December 26, 2017
    Report Date
    April 11, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK002083
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). AGE AND PATIENT SEX: CLARIFICATION WAS REQUESTED AS THE PATIENT WAS ORIGINALLY REPORTED AS A (B)(6) FEMALE AND THE ADDITIONAL INFORMATION STATES PATIENT IS A YOUNG MALE. CONCOMITANT MEDICAL PRODUCT: BIOMET MICROFIXATION LACTOSORB SYSTEM 1.5MM SELF-DRILLING LACTOSORB TAP, DENSE BONE CATALOG #: 915-1590-01 LOT #: 780750. THERAPY DATE: (B)(6) 2017. REPORT SOURCE: FOREIGN COUNTRY - (B)(6). CUSTOMER HAS INDICATED THAT THIS PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, IT REMAINS IMPLANTED IN THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2018-00084.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE PRODUCTS NOT BEING RETURNED, THEREFORE THE COMPLAINT CANNOT BE VERIFIED AND THE MOST LIKELY UNDERLYING CAUSE CANNOT BE DETERMINED. THE DIFFICULTY WRENCHING OFF THE HEX HEAD WAS LIKELY DUE TO THE INABILITY TO FIXATE THE SCREW PROPERLY. 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 AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 TAP INVOLVED IN THIS EVENT, WHICH WAS REPORTED IN 0001032347-2018-00084, WAS RETURNED AND THE EVALUATION IS IN PROGRESS. (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2018-00084-2.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PLACING THE SCREW IN THE ZYGOMATIC REGION, "THE SURGEON COULD NOT FIX THE SCREW COMPLETELY AND WRENCH OFF THE HEX HEAD ALTHOUGH THE SURGEON ATTEMPTED TO INSERT THE SCREW AFTER USING BOTH TAPS. THE SURGEON STATED THAT DIAMETER OF BOTH TAPS WERE MORE LARGE THAN THE TRADITIONAL TAP. THE SURGERY WAS COMPLETED AFTER REMAINED HEX HEAD OF SCREWS WERE MELTED USING HEAT PEN." THERE WAS NO SURGICAL DELAY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. IN RESPONSE TO REQUESTS FOR ADDITIONAL INFORMATION THE CUSTOMER REPORTED THE PATIENT'S BONE WAS EXPECTED DENSE BECAUSE THE PATIENT WAS YOUNG MALE. THE SURGEON EXPERIENCED DIFFICULTY REMOVING THE HEX HEAD ON FOUR SCREWS. IT IS UNKNOWN IF THE TAP CREATED LARGER HOLES OR IF BIGGER SCREWS WERE NEEDED AS A RESULT. IT WAS CONFIRMED THE SCREWS WERE FIXED FULLY USING THE HEAT PEN.

    Description of Event or Problem · 1

    THE CUSTOMER CONFIRMED THE PATIENT IS A (B)(6) FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174253 1.5 LACTOSORB SYSTEM 1.5 X 5 MM LACTOSORB SCREW BONE SCREW JEY BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR