BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY OSCILLATOR II

    MDR report key: 3924950 · Received July 10, 2014

    Report

    Report Number
    3009450871-2014-10240
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GEY
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: MOQ. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS COMPLETED: THE OPTICAL CHECK WAS OK; THE DEVICE WAS IN GOOD GENERAL CONDITION. TWO PINS COMING LOOSE AND MOVING UPWARDS FROM THE OSCILLATING HEAD BASE ((B)(4)) INSPECTED BY THE VISUAL INSPECTION CAN BE CONFIRMED. THE AFFECTED BATTERY OSCILLATOR II WAS MANUFACTURED IN (B)(4). EXCEEDING OF TOLERANCE RANGE DURING THE MANUFACTURING PROCESS OF THE OSCILLATING HEAD BASE COULD BE IDENTIFIED. THE DIAMETER OF THE PINS WAS TOO SMALL FOR THE HOLE AND/OR THE HOLE WAS TOO BIG FOR THE PINS. THEREFORE THE PINS COULD NOT BE PRESSED IN AS TIGHTLY AS SPECIFIED. ACCORDING TO THE NON-CONFORMITY REPORT THE FUNCTIONALITY OF THE DEVICE IS ENSURED EVEN IN CASE OF FAULTY PINS. HOWEVER, AS A CONSEQUENCE THE SAW BLADE COULD NOT BE REMOVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A CASE ON (B)(6) 2014, THE CUTTING BLADE BECAME STUCK ON TO THE OSCILLATOR MACHINE. IT APPEARS THAT TWO OF EIGHT PINS THAT HOLD THE BLADE HAD COME LOOSE AND ROSE UP PREVENTING THE BLADE FROM DETACHING. THE SURGERY WAS DELAYED BY APPROXIMATELY SEVEN MINUTES. DURING THIS TIME, A SECOND SAW HAD TO BE USED TO COMPLETE THE SURGERY. THERE WAS NO HARM TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404972 BATTERY OSCILLATOR II MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1