BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLUBE-III WITH IRRIGATION

    MDR report key: 3984251 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-15869
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Report Date
    February 11, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GEY
    PMA / PMN Number
    K970530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES. THE DEVICE WAS EVALUATED AND THE REPORTED CONDITION OF THE "LOW POWER" COULD NOT BE CONFIRMED. HOWEVER, DURING SERVICE AND REPAIR, DEVICE FAILURES WERE FOUND, BUT WERE NOT RELATED TO THE REPORTED EVENT. IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING THAT THE DEVICE HAD LOW POWER. IT IS KNOWN THAT THE DEVICE WAS BEING USED DURING SURGERY. IT IS ALSO KNOW THAT THERE WAS NOT PATIENT INJURY; HOWEVER, IT IS UNK IF THERE WAS ANY MEDICAL INTERVENTION OR SURGICAL DELAY RELATED TO THE EVENT. THERE IS A DISCREPANCY IN THE DATE OF THE EVENT ((B)(6) 2011) AND DEVICE RETURNED DATE ((B)(6) 2011), WHICH IS BELIEVED TO BE DUE TO AN ENTRY ERROR. ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER REGARDING ADDITIONAL INFO, BUT NO ADDITIONAL INFO WAS OBTAINED AND THE EXACT DATE OF THE EVENT IS UNK. NO ADDITIONAL INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663856 AUTOLUBE-III WITH IRRIGATION GEY DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1