BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL INSERTER/EXTRACTOR

    MDR report key: 6652972 · Received June 20, 2017

    Report

    Report Number
    0001825034-2017-04082
    Event Type
    Malfunction
    Date Received
    June 20, 2017
    Report Date
    March 9, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HWB
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO PRODUCT BEING SCRAPPED PRIOR TO EVALUATION. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. MULTIPLE REPORTS WERE SUBMITTED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-04082-1, 0001825034-2017-04083-1, 0001825034-2017-04084-1.

    Additional Manufacturer Narrative · 1

    (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: 0001825034-2017-04083, 0001825034-2017-04084.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THREADED TIPS WERE STRIPPED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435374 UNIVERSAL INSERTER/EXTRACTOR EXTRACTOR HWB BIOMET ORTHOPEDICS N/A ZB141201

    Patients

    Seq Age Sex Outcome Treatment
    1