BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0 LACTOSORB SYSTEM 2.0 X 7 MM DIRECT DRIVE SCREW

    MDR report key: 11298257 · Received February 8, 2021

    Report

    Report Number
    0001032347-2021-00059
    Event Type
    Malfunction
    Date Received
    February 8, 2021
    Date of Event
    January 13, 2021
    Report Date
    April 29, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    UDI-DI
    00841036054700
    PMA / PMN Number
    K011139
    Removal / Correction Number
    NI
    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. TWO SCREWS WERE RETURNED WITH DAMAGE. ONE SCREW HAS VISIBLE DAMAGE, WHILE THE OTHER ONE HAS SUBSTANTIAL DAMAGE TO THE HEAD. ITEM AND LOT NUMBERS ARE CONFIRMED TO MATCH THE PRODUCT LABEL. DIMENSIONAL TESTING WAS NOT COMPLETED DUE TO DAMAGE TO THE SCREW HEADS. 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 DUE TO ATTEMPTED USE. 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 D1, D2, D4, D9, D10, E4, H2, H3, H6 AND H10. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2021-00240 D10 ¿ MEDICAL PRODUCTS 2.0 LACTOSORB SYSTEM 2.0 X 7 MM DIRECT DRIVE SCREW, PART# 915-2201, LOT# 893690

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). FOREIGN - EVENT OCCURRED IN (B)(6). 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. 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 · 1

    IT WAS REPORTED THAT APPROXIMATELY THREE AND A HALF (3.5) WEEKS AGO, THE SCREW COULD NOT BE GRIPPED. PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189586 2.0 LACTOSORB SYSTEM 2.0 X 7 MM DIRECT DRIVE SCREW SCREW, FIXATION, BONE HWC BIOMET MICROFIXATION NI 893690 00841036054700

    Patients

    Seq Age Sex Outcome Treatment
    1