BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUGGLES MICRO DISSECTOR NEEDLE SEMI-SHARP

    MDR report key: 11735356 · Received April 27, 2021

    Report

    Report Number
    2523190-2021-00080
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Report Date
    June 18, 2021
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    GZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE RUGGLES MICRO DISSECTOR NEEDLE (PRODUCT ID: RN6212) WAS RETURNED FOR EVALUATION: FAILURE ANALYSIS: VISUAL INSPECTION WAS PERFORMED AND THE RETURNED NEEDLE HAD AN EXTRA PORTION ON ITS TIP DUE TO MANUFACTURING ERROR. ROOT CAUSE:THE REPORTED COMPLAINT IS CONFIRMED. THE RETURNED RN6212 NEEDLE IS IN USED CONDITION WITH AN IRREGULAR TIP DUE TO MANUFACTURE ERROR. INSPECTION HAS BEEN INITIATED AT THE LDC. NO FURTHER INVESTIGATION REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FACILITY REPORTED THAT THE TIP OF RUGGLES MICRO DISSECTOR NEEDLE (PRODUCT ID RN6212) WAS BENT AND THE SHAPE WAS NOT REGULAR. THERE WAS NO REPORTED PATIENT INJURY AND NO DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632027 RUGGLES MICRO DISSECTOR NEEDLE SEMI-SHARP MICROSURGICAL INSTRUMENTATION GZX INTEGRA YORK, PA INC. AV1812

    Patients

    Seq Age Sex Outcome Treatment
    1