BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0 LACTOSORB SYSTEM 2.0 X 7 MM DIRECT DRIVE SCREW

    MDR report key: 10532241 · Received September 14, 2020

    Report

    Report Number
    0001032347-2020-00439
    Event Type
    Malfunction
    Date Received
    September 14, 2020
    Date of Event
    August 28, 2020
    Report Date
    February 15, 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 QTY ONE 915-2201 LOT 565560 LACTOSORB SCREW FOR EVALUATION DUE TO LACK OF RETENTION COMPLAINT. A VISUAL INSPECTION OF THE SCREW SHOWED LIGHT SIGNS OF ATTEMPTED USE. FOR FURTHER ANALYSIS THE SCREW WAS RETURNED TO WARSAW FOR FURTHER INVESTIGATION BY THE OPS MANUFACTURING TECHNICIAN. THE REPORTED TESTING RESULT SHOWS THAT THE RETURNED PRODUCT WAS FOUND TO FAIL THE NO-GO TEST AND HAS BEEN DEEMED OUT OF SPEC. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO ISSUES IN THE MANUFACTURING PROCESS LEADING TO UNDERSIZED PARTS BEING MANUFACTURED. 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

    NO FURTHER EVENT INFORMATION 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. MEDICAL PRODUCTS: LACTOSORB SYSTEM LACTOSORB DIRECT DRIVER BLADE, PART# 915-2451, LOT# NI. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. REPORT SOURCE ¿ (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE SCREWS COULD NOT BE GRASPED BY MULTIPLE BLADES DURING A MAXILLARY LEFORT I OSTEOTOMY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995359 2.0 LACTOSORB SYSTEM 2.0 X 7 MM DIRECT DRIVE SCREW SCREW, FIXATION, BONE HWC BIOMET MICROFIXATION N/A 565560 00841036054700

    Patients

    Seq Age Sex Outcome Treatment
    1