BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXFORD GAP GAUGE 8/9 SM

    MDR report key: 9779382 · Received March 3, 2020

    Report

    Report Number
    3002806535-2020-00111
    Event Type
    Malfunction
    Date Received
    March 3, 2020
    Date of Event
    February 5, 2020
    Report Date
    April 22, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, ASSOCIATED REPORTS: 3002806535-2020-00110-1. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. IN ADDITION, WE HAVE NOT BEEN PROVIDED WITH ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE MANUFACTURING HISTORY RECORDS COULD NOT BE PERFORMED AS LOT NUMBER IS NOT AVAILABLE. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND 2 SIMILAR COMPLAINTS REPORTED WITH THE ITEM (B)(4) AND NO SIMILAR COMPLAINT WITH (B)(4). NO TREND IDENTIFIED. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE EXPLANTATION OF THE INSTRUMENT, THE OXFORD SM SIZE 3 BEARING TRIAL BROKE. LATER IN THE SAME CASE THE PLASTIC TIP OF THE TIBIA TRAY IMPACTOR CHIPPED OFF DURING TIBIAL IMPACTION. THERE WAS NO DELAY AND NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. MEDICAL PRODUCT: OXF TRL BRG W/SLOTS SML 3MM, CATALOG #: 32-422698, LOT #: UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00110. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE EXPLANTATION OF THE INSTRUMENT, THE OXFORD SM SIZE 3 BEARING TRIAL BROKE. LATER IN THE SAME CASE THE PLASTIC TIP OF THE TIBIA TRAY IMPACTOR CHIPPED OFF DURING TIBIAL IMPACTION. THERE WAS NO DELAY AND NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246558 OXFORD GAP GAUGE 8/9 SM ORTHOPAEDIC FEELER JWH BIOMET UK LTD. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other