BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0 LACTOSORB SYSTEM 2.5 X 7MM DIRECT DRIVE SCREW

    MDR report key: 11121459 · Received January 5, 2021

    Report

    Report Number
    0001032347-2021-00003
    Event Type
    Malfunction
    Date Received
    January 5, 2021
    Date of Event
    December 14, 2020
    Report Date
    May 3, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    UDI-DI
    00841036054779
    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. ONE SCREW FROM LOT 769250 WAS RETURNED WITH THE HEAD AND THREADS DAMAGED AND COVERED IN BLOOD. TWO SCREWS FROM LOT 893690 WERE RETURNED. ONE IS FRACTURED AND THE OTHER IS DEFORMED AND COVERED IN BLOOD. ITEM AND LOT NUMBERS ARE CONFIRMED TO MATCH THE COMPLAINT WITH PACKAGE LABELS. DIMENSIONAL TESTING WAS NOT COMPLETED DUE TO DAMAGE TO THE SCREW HEAD. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED DUE TO THE INABILITY TO DIMENSIONALLY MEASURE THE PRODUCT BECAUSE OF THE PRODUCT DAMAGE. A POSSIBLE GAUGE ISSUE WAS IDENTIFIED AND AN ISSUE EVALUATION WAS PREVIOUSLY INITIATED FOR FURTHER EVALUATION. 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. THIS REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION IN SECTION B5, D4, D9, D10, H2, H3, H6 AND H10. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2021-00002, 0001032347-2021-00238 D11 ¿ MEDICAL PRODUCTS 2.0 LACTOSORB SYSTEM 2.0 X 7 MM DIRECT DRIVE SCREW, PART# 915-2201, LOT# 893690 2.0 LACTOSORB SYSTEM 2.0 X 7 MM DIRECT DRIVE SCREW, PART# 915-2201, LOT# 893690

    Description of Event or Problem · 0

    IT WAS REPORTED TWO (2) SCREWS COULD NOT BE GRIPPED AND ONE (1) SCREW BROKE BECAUSE IT WAS TOO TIGHT TO PULL OUT OF THE SCREWDRIVER DURING A MAXILLARY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SCREW. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTIONS.

    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 REPORTS: 0001032347-2021-00002. MEDICAL PRODUCTS: 2.0 LACTOSORB SYSTEM 2.0 X 7 MM DIRECT DRIVE SCREW, PART# 915-2201, LOT# 893690 2.0 LACTOSORB SYSTEM 2.5 X 7MM DIRECT DRIVE SCREW, PART# 915-2208, LOT# 769250 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 ONE (1) SCREW COULD NOT BE GRIPPED AND ONE (1) SCREW BROKE BECAUSE IT WAS TOO TIGHT TO PULL OUT OF THE SCREWDRIVER DURING A MAXILLARY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SCREW. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17849 2.0 LACTOSORB SYSTEM 2.5 X 7MM DIRECT DRIVE SCREW SCREW, FIXATION, BONE HWC BIOMET MICROFIXATION N/A 769250 00841036054779

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10 NARRATIVE| SEE H10 NARRATIVE