BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREDRILLING ASSEMBLY-SHORT APEX Ø 5MM

    MDR report key: 2930124 · Received January 25, 2013

    Report

    Report Number
    0008031020-2013-00003
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED INCIDENT COULD NOT BE CONFIRMED, SINCE THE RETURNED DEVICE IS FULLY FUNCTIONAL. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. BASED ON THE INVESTIGATION RESULTS, THIS CASE COULD BE CLASSIFIED AS A NON ISSUE. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED. IF THE PIN IS RETURNED, THIS INVESTIGATION REPORT WILL BE UPDATED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PIN IS STUCK .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PIN IS STUCK .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35536 PREDRILLING ASSEMBLY-SHORT APEX Ø 5MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-SELZACH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other