BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIGLI WIRE SAW IN 6 PARTS 300MM LONG

    MDR report key: 12820515 · Received November 16, 2021

    Report

    Report Number
    9610612-2021-00713
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Date of Event
    October 12, 2021
    Report Date
    January 21, 2022
    Manufacturer
    AESCULAP AG
    Product Code
    GDR
    UDI-DI
    04038653341153
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: AS OF THE DATE OF THIS REPORT THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. THEREFORE, A THOROUGH INVESTIGATION IS NOT POSSIBLE. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS WERE NOT ABLE TO BE CHECKED AS NO LOT NUMBER WAS PROVIDED. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT PRODUCT WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FH413 - GIGLI WIRE SAW IN 6 PARTS 300MM LONG. ACCORDING TO THE COMPLAINT DESCRIPTION, A JIGSAW WAS USED TO REMOVE THE ACETABULUM DURING SALTER SURGERY. AFTER SURGERY, MRI IMAGING WAS PERFORMED, AND IT WAS CONFIRMED THAT HALATION (ARTIFACT) APPEARED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1723298 GIGLI WIRE SAW IN 6 PARTS 300MM LONG INSTRUMENTS FOR NEUROSURGERY GDR AESCULAP AG FH413 04038653341153

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown