BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR ASSEMBLY OMEGA

    MDR report key: 3071530 · Received April 22, 2013

    Report

    Report Number
    0008031020-2013-00108
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT THAT THE IMPACTOR ASSEMBLY BROKE COULD BE CONFIRMED SINCE THE PROVIDED PICTURE SHOWS 2 BROKEN DEVICES. BASED ON INVESTIGATION AND WITHOUT THE AFFECTED DEVICE THE ROOT CAUSE OF THE DETERMINED BREAKAGE COULD NOT BE DETERMINED. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. PLEASE NOTE THAT THE CURRENT OP TECHNIQUE READS: IMPACTION OF THE FRACTURE MAY BE ACCOMPLISHED BY USING THE PLATE IMPACTOR TOGETHER WITH A HAMMER OR MALLET NOTE: USE GENTLE HAMMERING ONLY - OTHERWISE THE IMPACTOR MAY BE DESTROYED. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION. PLEASE NOTE THAT MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    SURGEON BROKE 2 X OMEGA IMPACTORS IN AN AFTERHOURS CASE (9PM) ON (B)(6) 2013.

    Description of Event or Problem · 1

    SURGEON BROKE 2 X OMEGA IMPACTORS IN AN AFTERHOURS CASE (9PM) ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171082 IMPACTOR ASSEMBLY OMEGA INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-SELZACH W31279

    Patients

    Seq Age Sex Outcome Treatment
    1 Other