BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR HEAD

    MDR report key: 11164384 · Received January 13, 2021

    Report

    Report Number
    0008031020-2021-00021
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    December 21, 2020
    Report Date
    March 10, 2021
    Manufacturer
    STRYKER GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD BE CONFIRMED, SINCE THE DEVICE WAS RETURNED FOR EVALUATION AND MATCHES THE ALLEGED FAILURE MODE. DEVICE INSPECTION REVEALED THE FOLLOWING: THE IMPACTOR HEAD WAS RECEIVED BROKEN IN TWO PARTS. THE BREAKAGE, WAS JUST AROUND THE MIDDLE. THE OVERALL BREAKAGE LOOKED TO BE CLEAN. INDICATING, TOWARDS A SUDDEN BREAKAGE ALONG THE WEAKER REGIONS. HOWEVER, SURFACE AT THE POINT OF DETACHMENT SHOWED, SLIGHT MATERIAL DEFORMATION AND WAVES. SUGGESTING TOWARDS HEAVY EXTERNAL IMPACTS. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE, ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND, DURING THE INVESTIGATION. 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 IMPACTIONS ON THE IMPACTOR AS EVIDENT BY THE MANNER OF DEFORMATION AND BREAKAGE SURFACE. THE DEVICE IS MEANT FOR ONLY GENTLE HAMMERING. THE OP-TECH CLEARLY WARNS THE USER THAT: ¿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 704001-1 (IMPACTOR HEAD OMEGA) BROKE, DURING AN OMEGA PLATE IMPLANTATION".

    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 704001-1 (IMPACTOR HEAD OMEGA) BROKE DURING AN OMEGA PLATE IMPLANTATION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57473 IMPACTOR HEAD ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER GMBH 02744V

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR