BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0 LACTOSORB SYSTEM 2.0 X 5 MM DIRECT DRIVE SCREW

    MDR report key: 11050061 · Received December 21, 2020

    Report

    Report Number
    0001032347-2020-00620
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Date of Event
    November 19, 2020
    Report Date
    March 23, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    UDI-DI
    00841036054687
    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 FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, G3, G6, H2, H3, H6, H10. THE CUSTOMER RETURNED QTY TWO 915-2200 LOT 865090, QTY TWO 915-2201 LOT 893700, AND QTY TWO 915-2200 LOT 056430 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 RESULTS SHOW THAT THE RETURNED SCREWS WERE POSSIBLY 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2020-00620, 0001032347-2020-00621, 0001032347-2020-00622. CONCOMITANT MEDICAL PRODUCTS: 2.0 LACTOSORB SYSTEM 2.0 X 5 MM DIRECT DRIVE SCREW, PART# 915-2200, LOT# 865090, 2.0 LACTOSORB SYSTEM 2.0 X 7 MM DIRECT DRIVE SCREW, PART# 915-2201, LOT# 893700, 2.0 LACTOSORB SYSTEM 2.0 X 5 MM DIRECT DRIVE SCREW, PART# 915-2200, LOT# 056430. 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 THAT THE SCREWS COULD NOT GRIPPED DURING AN ORAL SURGERY. SOME OF THE SCREWS WERE TOO TIGHT AND SOME OF THE SCREWS WERE TOO LOOSE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1511526 2.0 LACTOSORB SYSTEM 2.0 X 5 MM DIRECT DRIVE SCREW SCREW, FIXATION, BONE HWC BIOMET MICROFIXATION N/A 865090 00841036054687

    Patients

    Seq Age Sex Outcome Treatment
    1