BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR ASSEMBLY OMEGA

    MDR report key: 10672179 · Received October 13, 2020

    Report

    Report Number
    0008031020-2020-02323
    Event Type
    Malfunction
    Date Received
    October 13, 2020
    Date of Event
    September 17, 2020
    Report Date
    December 16, 2020
    Manufacturer
    STRYKER GMBH
    Product Code
    LXH
    UDI-DI
    04546540113078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD BE CONFIRMED, SINCE THE DEVICE WAS RETURNED FOR EVALUATION (ALTHOUGH INCOMPLETE) AND MATCHES THE ALLEGED FAILURE MODE. DEVICE INSPECTION REVEALED THE FOLLOWING: THE RECEIVED IMPACTOR HEAD WAS FOUND TO BE SEVERELY DEFORMED AROUND THE DISTAL END. THE METALLIC HANDLE WAS NOT RECEIVED ALONG WITH THE HEAD. THE DEFORMATION AROUND THE DISTAL END INDICATES TOWARDS APPLICATION OF ABNORMAL AMOUNT OF FORCES. ALSO, THE OUTER SURFACE SHOWS UNUSUAL MARKS AND SCRATCHES INDICATING TOWARDS LONG AND PROLONGED USAGE. THE PRODUCT RECEIVED WAS INCOMPLETE. OF THE WHOLE ASSEMBLY, ONLY THE HEAD WAS RECEIVED, AND THE METAL HANDLE WAS NOT RETURNED. SINCE THE PRODUCT IDENTIFICATION IS AVAILABLE ONLY ON THE METAL HANDLE, THE LOT NUMBER COULD NOT BE IDENTIFIED. THEREFORE, A PRODUCT HISTORY REVIEW COULD NOT BE PERFORMED. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. BASED ON THE ABOVE INVESTIGATION, THE ROOT CAUSE OF THE FAILURE IS USER RELATED. THERE ARE SIGNS OF HEAVY ABNORMAL IMPACTIONS EVIDENT QUITE CLEARLY ON THE HEAD PORTION OF THE DEVICE. ALSO, AS THE DEVICE IS INTENTIONALLY USED FOR IMPACTION, IT IS FOR SURE THAT A WEAKENED STRUCTURED INTEGRITY DUE TO LONG USAGE AND REPROCESSING CYCLES WOULD HAVE CONTRIBUTED TO THE FAILURE. THE OP-TECH STATES: ¿NOTE: USE GENTLE HAMMERING ONLY OTHERWISE THE IMPACTOR MAY BE DESTROYED.¿ IF ANY FURTHER INFORMATION IS PROVIDED, THE COMPLAINT REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    AS REPORTED: "THE SCREW-ON ATTACHMENT (704001-1) OF THE PLATE HAMMER IS BROKEN".

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF INVESTIGATION, ADDITIONAL INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    AS REPORTED: "THE SCREW-ON ATTACHMENT (704001-1) OF THE PLATE HAMMER IS BROKEN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137903 IMPACTOR ASSEMBLY OMEGA ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER GMBH 704001 UNKNOWN 04546540113078

    Patients

    Seq Age Sex Outcome Treatment
    1