BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER DRIVE

    MDR report key: 3132456 · Received May 29, 2013

    Report

    Report Number
    2520274-2013-02817
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE SERIAL NUMBER (B)(4) BELONGS TO THE PART 50140442, WHICH IS THE HOUSING OF THE ARTICLE 530.100. THE MANUFACTURING DOCUMENTS OF THIS HOUSING WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. UPON FURTHER REVIEW OF THE COMPLAINT, IT WAS DETERMINED THE COMPLAINT IS NOT REPORTABLE DUE TO: DOES NOT MEET THE DEFINITION OF AN MDR REPORTABLE EVENT. NOT LIKELY TO RESULT IN PATIENT HARM OR THE NEED FOR ADDITIONAL MEDICAL OR SURGICAL INTERVENTION. THE MDR REPORT ABILITY STATUS UPDATED TO: DOES NOT MEET THE DEFINITION OF A REPORTABLE EVENT. SYNTHES IS RETRACTING MEDWATCH REPORT: #2520274-2013-02817.NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    Description of Event or Problem · 1

    IT WAS REPORTED, DURING A SURGICAL PROCEDURE ON (B)(6) 2013, THE POWER DRIVE WOULD NOT TURN ON. SEVERAL DIFFERENT BATTERIES WERE TRIED BUT THE DEVICE STILL DID NOT FUNCTION. IT WAS ALSO REPORTED THE PROCEDURE WAS COMPLETED UTILIZING A BACKUP DEVICE. THE EVENT CAUSED AN APPROXIMATE FIVE MINUTE DELAY IN COMPLETING THE PROCEDURE. THIS REPORT IS FOR A POWER DRIVE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237198 POWER DRIVE GEY SYNTHES (USA) 36358

    Patients

    Seq Age Sex Outcome Treatment
    1