BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC PEN DRIVE 60,000 RPM

    MDR report key: 2933377 · Received January 29, 2013

    Report

    Report Number
    8030965-2013-00233
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE WAS RECEIVED AT SYNTHES (B)(4); DATE UNKNOWN. SYNTHES (B)(4) RELIABILITY ENGINEERING EVALUATED THE DEVICE, AND THE REPORTED PROBLEM WAS CONFIRMED; THE DEVICE WAS TESTED AND WOULD NOT ENGAGE WHEN POWER WAS APPLIED. THE UNIT EXHIBITED DAMAGE THAT WAS CONSISTENT WITH IMMERSION IN WATER. THIS CONDITION IS INDICATIVE OF IMPROPER CLEANING OF THE DEVICE. WE RECOMMEND THAT THE USER REVIEW THE CLEANING AND MAINTENANCE PROCEDURES FOR THE DEVICE. PROPER CLEANING AND MAINTENANCE ARE REQUIRED IN ORDER TO ENSURE TROUBLE-FREE OPERATION. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: THE FACILITY CALLED IN A REPAIR REQUEST FOR AN ELECTRIC PEN DRIVE THAT WAS TO BE USED IN CLOSED TREATMENT OF DISTAL RADIAL FRACTURE SURGERY WHEN IT WAS DISCOVERED IT WOULD NOT WORK PROPERLY-LOSING POWER AND RUNNING INTERMITTENTLY. IT WAS REPORTED APPROXIMATELY A 2 MINUTE DELAY FOR THE PRODUCT ON HAND. THE INTENT WAS TO USE PRODUCT DURING SURGERY BUT DUE TO THE POWER ISSUE IT WAS NOT USED ON THE ACTUAL PATIENT. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED; NO USED REPORT WAS FILED. ALL AVAILABLE PATIENT INFORMATION HAS BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39592 ELECTRIC PEN DRIVE 60,000 RPM ELECTRIC PEN DRIVE HWE SYNTHES GMBH 1277

    Patients

    Seq Age Sex Outcome Treatment
    1