BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD KNEE RESECTION PROCEDURE 3 PACK

    MDR report key: 1569394 · Received December 21, 2009

    Report

    Report Number
    1569394
    Event Type
    Injury
    Date Received
    December 21, 2009
    Date of Event
    December 14, 2009
    Report Date
    December 18, 2009
    Manufacturer
    SYNVASIVE TECHNOLOGY, INC.
    Product Code
    GFA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING OXFORD PARTIAL KNEE REPLACEMENT THE PT SUSTAINED A SMALL TEAR OF THE SUPERFICIAL MEDIAL COLLATERAL LIGAMENT. A STRYKER SYSTEM 5 SAW WAS USED WITH A SYNVASIVE OXFORD PARTIAL KNEE SAW BLADE. THE SAW BLADE WAS ACTUALLY MADE TO FIT A STRYKER SYSTEM 6 SAW. THE SAW BLADES WERE ORDERED USING A REFERENCE NUMBER SUPPLIED BY THE MANUFACTURER. THE BLADE SEATED AND CLICKED INTO PLACE IN THE SAW BUT WAS SOMEWHAT "WOBBLY" AND WHEN THE SAW WAS ACTIVATED IT "JUMPED" AND CAUSED A NICK IN THE MEDIAL COLLATERAL LIGAMENT. THIS WAS IMMEDIATELY NOTED AND A SUTURE WAS PLACED IN THE RENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXFORD KNEE RESECTION PROCEDURE 3 PACK SAW BLADE GFA SYNVASIVE TECHNOLOGY, INC. 94120

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention THE BLADE WAS USED WITH A STRYKER SYSTEM 5 SAW