BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ME1000 BROACH-ADAPTER-ANTERIOR

    MDR report key: 8011528 · Received October 28, 2018

    Report

    Report Number
    1045834-2018-51955
    Event Type
    Malfunction
    Date Received
    October 28, 2018
    Date of Event
    October 9, 2018
    Report Date
    October 9, 2018
    Manufacturer
    DEPUY SYNTHES PRODUCTS LLC
    Product Code
    GEY
    UDI-DI
    850915006044
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. DURING REPAIR, IT WAS DETERMINED THAT THE DEVICE LOCKING MECHANISM IS POPPING UP DURING USE. THE ADAPTER WAS MANUFACTURED PRE-DESIGN CHANGE THE DESIGN CHANGE REMOVED MATERIAL FROM TWO DIFFERENT SURFACES TO IMPROVE THE LATCHING MECHANISM BY ALLOWING THE LEAVER TO TRAVEL FURTHER WHEN CLOSING. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO COMPONENT DAMAGE FROM DEVICE NOT BEING COMPATIBLE. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER LOCATION WAS DOCUMENTED AS DEPUY SYNTHES PRODUCTS LLC IN (B)(4) IN THE INITIAL REPORT. THE LOCATION HAS BEEN UPDATED TO TECHTRONIC INDUSTRIES MEDICAL INC. CONTACT OFFICE NAME/ADDRESS HAS BEEN UPDATED ACCORDINGLY TO REFLECT THE CORRECT MANUFACTURING FACILITY. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    THIS IS EVENT 2 OF 5 OF THE SAME EVENT. IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT FIVE ADAPTER DEVICE LOCKING MECHANISM'S WAS POPPING UP DURING USE. IT WAS UNKNOWN IF THERE WERE DELAYS TO THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO 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
    852073 ME1000 BROACH-ADAPTER-ANTERIOR MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY DEPUY SYNTHES PRODUCTS LLC NA 850915006044

    Patients

    Seq Age Sex Outcome Treatment
    1