BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCR,5/PK

    MDR report key: 10785892 · Received November 4, 2020

    Report

    Report Number
    0001032347-2020-00557
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Date of Event
    October 19, 2020
    Report Date
    February 11, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    UDI-DI
    00841036056650
    PMA / PMN Number
    K121589
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. A VISUAL INSPECTION WAS CARRIED OUT ON THE RETURNED 95-6104 SCREWS. THE SCREWS SHOW HEAVY SIGNS OF USE/ DAMAGE. THE SCREW HEADS ON THE RETURNED SCREWS HAVE FRACTURED WHERE THE SCREW HEAD MEETS THE SCREW SHAFT. THERE IS ALSO DAMAGE TO THE SCREW THREADS AND SCREW TIPS. THE COMPLAINT IS CONFIRMED. MEASUREMENTS ARE UNABLE TO BE PERFORMED DUE TO THE DAMAGE TO THE SCREWS. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE SCREWS FRACTURED UPON INSERTION DURING AN EXTRAOCULAR CRANIOTOMY. THE TIPS OF THE SCREWS WERE FOUND DURING THE OPERATION AND NO PIECE OF THE FRACTURED SCREWS REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ALTERNATE PRODUCTS. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT: (B)(4). 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2020-00558. MEDICAL PRODUCTS: 1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCR,5/PK, PART# 95-6104, LOT# 443850; 1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCR,5/PK, PART# 95-6104, LOT# 443760. THE USER FACILITY IS FOREIGN, THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. FOREIGN SOURCE: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE SCREWS FRACTURED DURING INSERTION. THE TIPS OF THE SCREWS WERE FOUND DURING THE OPERATION. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249905 1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCR,5/PK PLATE, BONE JEY BIOMET MICROFIXATION N/A 443850 00841036056650

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR