BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0 LACTOSORB SYSTEM 2.0 X 7 MM DIRECT DRIVE SCREW

    MDR report key: 11121453 · Received January 5, 2021

    Report

    Report Number
    0001032347-2021-00001
    Event Type
    Malfunction
    Date Received
    January 5, 2021
    Date of Event
    December 9, 2020
    Report Date
    March 19, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    UDI-DI
    00841036054700
    PMA / PMN Number
    K011139
    Removal / Correction Number
    N/A
    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. THE CUSTOMER RETURNED THE (B)(6), LOT 893690 SCREWS FOR EVALUATION DUE TO LACK OF RETENTION COMPLAINT. A VISUAL INSPECTION OF THE SCREWS SHOWED SIGNS OF ATTEMPTED USE. FOR FURTHER ANALYSIS THE SCREWS WERE RETURNED TO WARSAW FOR FURTHER INVESTIGATION BY THE OPS MANUFACTURING TECHNICIAN. THE REPORTED TESTING RESULTS SHOW THAT THE RETURNED SCREWS WERE DAMAGED AS THERE WERE IMPRINTS OF THE DRIVER TIP IN THE HEAD OF MOST THE SCREWS. DIMENSIONAL TESTING COULD NOT BE COMPLETED DUE TO THE DAMAGE TO THE SCREW HEADS. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.THE USER FACILITY IS FOREIGN;THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. REPORTER SOURCE: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON EXPERIENCED SCREW RETENTION ISSUES WITH FOUR (4) SCREWS DURING A MAXILLARY OSTEOTOMY. SOME SCREWS WERE TOO LOOSE TO GRIP AND SOME SCREWS WERE TOO TIGHT TO GRIP. THE PROCEDURE WAS COMPLETED WITH ALTERNATE DEVICES. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17846 2.0 LACTOSORB SYSTEM 2.0 X 7 MM DIRECT DRIVE SCREW SCREW, FIXATION, BONE HWC BIOMET MICROFIXATION N/A 893690 00841036054700

    Patients

    Seq Age Sex Outcome Treatment
    1