BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY OSCILLATOR II

    MDR report key: 3505976 · Received December 9, 2013

    Report

    Report Number
    8030965-2013-05462
    Event Type
    Malfunction
    Date Received
    December 9, 2013
    Report Date
    November 11, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL CODE: MOQ. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USE FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: USAGE OF DEVICE IS UNKNOWN. NOT PREVIOUSLY REPORTED. A SERVICE HISTORY OF THE PAST SIX MONTHS HAS BEEN REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT PREVIOUSLY BEEN IN FOR SERVICE. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. THE INVESTIGATION IS ON-GOING, AN ADDITIONAL EVALUATION/POWER TOOL EVALUATION HAS BEEN REQUESTED. (B)(4).

    Additional Manufacturer Narrative · 1

    TOTAL KNEE JOINT PROCEDURE, FOR CLARIFICATION. AN ADDITIONAL EVALUATION(POWER TOOL EVALUATION) WAS COMPLETED. THE PART RECEIVED CONDITION WAS A BLEMISHED HOUSING . THE REPORT CONCLUDED: THE CUSTOMER'S COMPLAINT THAT THE BLADE IS STUCK ON THE (100045) BATTERY OSCILLATOR WAS CONFIRMED. THE UNIT WAS TESTED AND IT WAS CONFIRMED THAT THE OSCILLATING HEAD IS DAMAGED. THE EVALUATION ENGINEER NOTES, THIS IS MOST LIKELY FROM NORMAL USE OVER TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL KNEE CASE, THE BATTERY OSCILLATOR MALFUNCTIONED. ONE OF THE NOTCHES IN THE SAW HEAD CAME OUT. THE BLADE COULD NOT BE REMOVED OR CHANGED IN THE FULLY OPEN POSITION. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    TOTAL KNEE JOINT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638642 BATTERY OSCILLATOR II GEY SYNTHES GMBH 100045

    Patients

    Seq Age Sex Outcome Treatment
    1