BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOBSTER BONE HOLDING FORCEPS

    MDR report key: 3023098 · Received March 27, 2013

    Report

    Report Number
    0008010177-2013-00053
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 5, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-FREIBURG
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VI, AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO FURTHER INFORMATION WAS PROVIDED. BASED ON THE AVAILABLE INFORMATION, THE ACTUAL ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. AS PER STATISTICAL EVALUATION, NO INDICATIONS WERE FOUND FOR ANY SYSTEMATIC, DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE. (B)(4): DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE AVAILABLE INFORMATION AND PERFORMED INTERNAL INVESTIGATION, THE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THERE WERE NO INDICATIONS FOUND FOR ANY MATERIAL OR MANUFACTURING RELATED ISSUE. (B)(4): DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FORCEPS BROKE DURING OPERATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FORCEPS BROKE DURING OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125386 LOBSTER BONE HOLDING FORCEPS FORCEPS LXH STRYKER OSTEOSYNTHESIS-FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1