BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ME1000 BROACH-ADAPTER-STRAIGHT

    MDR report key: 8038827 · Received November 5, 2018

    Report

    Report Number
    1045834-2018-52040
    Event Type
    Malfunction
    Date Received
    November 5, 2018
    Date of Event
    October 15, 2018
    Report Date
    October 15, 2018
    Manufacturer
    DEPUY SYNTHES PRODUCTS LLC
    Product Code
    GEY
    UDI-DI
    850915006006
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE THE EVALUATION OF THE DEVICE HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE DATE RETURNED TO MANUFACTURER WAS DOCUMENTED AS OCT 13, 2018 ON THE INITIAL REPORT. THIS DATE HAS BEEN UPDATED TO OCT 7, 2018. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY. DEVICE EVALUATION: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. THE BROACH ADAPTER DEVICE WAS EVALUATED AND THE REPORTED CONDITION THAT THE DEVICE FAILED LOCKING LATCH ATTACHMENT ASSESSMENT, LOCKING LATCH DOES NOT HOLD ADAPTER SECURELY, IT COMES LOOSE WAS CONFIRMED. AN ASSESSMENT WAS PERFORMED AND IT WAS OBSERVED THAT THE LOCKING LATCH DOES NOT HOLD ADAPTER SECURELY, IT COMES LOOSE. THE ADAPTER NO LONGER HOLDS BROACH SECURELY DUE TO THE WEAR OF THE JOINTS FROM THE LOCKING MECHANISM. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO WEAR FROM NORMAL USE OVER TIME. A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO NON-CONFORMANCES WERE DETECTED RELATED TO THE REPORTED CONDITION. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION IT WAS OBSERVED THAT THE LOCKING LATCH OF THE BROACH ADAPTER DEVICE DID NOT HOLD THE ADAPTER SECURELY AND IT BECAME LOOSE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED THE LOCKING LATCH ATTACHMENT ASSESSMENT. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880035 ME1000 BROACH-ADAPTER-STRAIGHT IMPACTOR, ADAPTERS, BATTERY, BATTERY CHARGER GEY DEPUY SYNTHES PRODUCTS LLC N/A 850915006006

    Patients

    Seq Age Sex Outcome Treatment
    1