BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR3 FOOTSWITCH *EA

    MDR report key: 8217215 · Received January 4, 2019

    Report

    Report Number
    1221934-2019-55906
    Event Type
    Malfunction
    Date Received
    January 4, 2019
    Date of Event
    January 2, 2019
    Report Date
    January 2, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HRX
    UDI-DI
    10886705009114
    PMA / PMN Number
    K041135
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT AVAILABLE FOR PHYSICAL EVALUATION, HENCE, THE COMPLAINT CANNOT BE CONFIRMED. GIVEN THE INFORMATION PROVIDED WE CANNOT DISCERN A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE. A DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT; THEREFORE, THERE IS NO EVIDENCE OF MANUFACTURING ANOMALIES ON THE PAPERWORK REVIEWED. AT THIS POINT, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA PHONE THAT PRIOR TO A SHOULDER REPAIR PROCEDURE, IT WAS OBSERVED THAT THE CUSTOMER'S VAPR 3 FOOTSWITCH (LOT: 0903015) DID NOT POWER ON. THE CASE WAS COMPLETED WITH A WIRELESS FOOTSWITCH WITH NO PATIENT HARM OR DELAY. THE SALES REP WAS NOT PRESENT FOR THE CASE AND COULD NOT PROVIDE ANY ADDITIONAL INFORMATION. THE DEVICE WAS DISCARDED BY THE CUSTOMER. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10865 VAPR3 FOOTSWITCH *EA FOOT-SWITCH, ELECTRICAL HRX DEPUY MITEK LLC US 0903015 10886705009114

    Patients

    Seq Age Sex Outcome Treatment
    1