BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSCILL-SAW-ATTACHM F/532.001 532.010 532

    MDR report key: 4092505 · Received September 16, 2014

    Report

    Report Number
    8030965-2014-01302
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    December 3, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO (B)(4) AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED A POWER SUPPLY DEFECT AND THAT THE DEVICE DOES NOT FUNCTION WHEN THE OSCILLATING SAW IS ATTACHED. THIS WAS ATTRIBUTED TO NORMAL WEAR. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON 02/06/2012. PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THIS PRODUCT WAS SENT BACK FROM THE REPAIR CENTER AFTER INSPECTION PERFORMED AT THE END OF NOVEMBER. "ALTHOUGH IT WORKS, PLEASE ASSEMBLE IT, BECAUSE THE BLADE ATTACHMENT CANNOT BE RESTORED TO HORIZONTAL POSITION. ALSO, PERHAPS BECAUSE IT CANNOT BE ASSEMBLED HORIZONTALLY, ATTACHMENTS BECOME TOO HOT TO TOUCH DURING OPERATION. THIS WAS NOT THE CASE PREVIOUSLY." THIS IS REPORT 1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572959 OSCILL-SAW-ATTACHM F/532.001 532.010 532 HWE SYNTHES GMBH 10504

    Patients

    Seq Age Sex Outcome Treatment
    1