BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPD 60000 RPM

    MDR report key: 3202751 · Received July 2, 2013

    Report

    Report Number
    8030965-2013-04195
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 3, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. AN INVESTIGATION WAS DONE AND IT STATES THAT THE MOTOR OF THE ELECTRIC PEN DRIVE DOES NOT REACT ACCORDING TO THE SPECIFIED VALUES WHEN DRIVING IT WITH THE HAND SWITCH. THIS EPD HAS BEEN DISMANTLED AND CHECKED FOR CONFORMANCE; A FAULTY SENSOR WAS DETECTED. UNFORTUNATELY THE EXACT REASON FOR THIS OCCURRENCE COULD NOT BE DETERMINED SO FAR AND THIS MATTER IS STILL UNDER INVESTIGATION AT THE MANUFACTURING SITE. AN INTERNAL INVESTIGATION WAS ALSO CONDUCTED. PLACEHOLDER.

    Description of Event or Problem · 1

    THIS IS REPORT NUMBER 1 OF 1 FOR COMPLAINT REPORT NUMBER (B)(4).

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) PROVIDES INFORMATION FROM A FACILITY IN (B)(6) REGARDING AN ELECTRIC PEN DRIVE. IT WAS REPORTED THAT DURING AN UNIDENTIFIED PROCEDURE, THE EPEN WOULD NOT STOP WHEN THE HAND SWITCH WAS TURNED OFF AND WHEN THE HAND SWITCH WAS TAKEN OFF THE HAND PIECE. THE EPEN DID NOT STOP MOVING WHEN THE SURGEON STOPPED BURRING. THE EPEN WITH BURR DRILLED INTO THE STERILE CLOTHS ON TOP OF THE PATIENT. REPORTEDLY THIS DID NOT CAUSE ANY HARM TO THE PATIENT. THIS IS REPORT NUMBER 1 OF 1 FOR COMPLAINT REPORT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301922 EPD 60000 RPM HWE SYNTHES GMBH SER.NR. 4802

    Patients

    Seq Age Sex Outcome Treatment
    1