BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY OSCILLATOR II

    MDR report key: 4111690 · Received September 23, 2014

    Report

    Report Number
    2520274-2014-13787
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL COMMON DEVICE NAME: MOQ. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AS PART OF THE MANUFACTURING INVESTIGATION REPORTED THE DEVICE ARRIVED AT THE SERVICE CENTER AS DISASSEMBLED COMPONENTS. THE RETURNED BATTERY OSCILLATOR HAS BEEN SENT TO THE MANUFACTURER FOR INVESTIGATION. THE SEPARATION OF THE SAW HEAD FROM THE HAND-PIECE BY THE VISUAL INSPECTION CAN BE CONFIRMED. THE ADHESIVE CONNECTION BETWEEN OSCILLATING HEAD AND SLEEVE SHOWS NO CONTINUOUS GLUE OF THE THREADED SURFACES. THIS COULD NOT BE FOUND IN NONCONFORMITY WITH SPECIFICATIONS IN THE FINAL QUALITY CONTROL. THE AFFECTED PARTS WERE MANUFACTURED IN (B)(4) FROM MAY TO NOVEMBER 2013. INITIAL INVESTIGATION IDENTIFIED PROBABLE ROOT CAUSE TO BE POOR PREPARATION AND APPLICATION OF LOCTITE GLUE ON THE AREA OF THE POWER TOOL DURING THE ASSEMBLY PROCESS. ESPECIALLY ON THE AREA WHERE THE OSCILLATING HEAD IS ATTACHED TO THE POWER TOOL. FURTHERMORE, A LACK OF EFFECTIVE WORK INSTRUCTIONS CONTRIBUTED TO THIS FAILURE. IN ORDER TO ACHIEVE A PRODUCT IMPROVEMENT, AN ADJUSTMENT OF THE RE-ASSEMBLING PROCESS WAS INTRODUCED ON (B)(6) 2014. NO FURTHER INVESTIGATIONS ARE REQUIRED 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 DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT NO NCRS NOTED IN THE PRODUCTION DOCUMENTATION. THE DEVICE HISTORY RECORD SHOWS NO ISSUES CONTRIBUTING TO THIS COMPLAINT. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE HEAD OF THE BATTERY OSCILLATOR BROKE DURING SURGERY, NO FRAGMENTS WERE LEFT IN THE PATIENT. SURGERY WAS DELAYED 5 MINUTES, THE CUSTOMER SWITCHED TO ANOTHER MACHINE THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591655 BATTERY OSCILLATOR II MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1