BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROCATING SAW ATTACHMENT FOR PEN DRIVE

    MDR report key: 3327630 · Received September 5, 2013

    Report

    Report Number
    2520274-2013-05905
    Event Type
    Malfunction
    Date Received
    September 5, 2013
    Date of Event
    August 7, 2013
    Report Date
    August 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.SERVICE HISTORY OF THE PAST SIX MONTHS WAS REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT PREVIOUSLY BEEN SENT IN FOR SERVICE. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE.(B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES DZI, ERL AND HBE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN UNKNOWN SURGERY, THE RECIPROCATING SAW ATTACHMENT FOR A PEN DRIVE STOPPED WORKING. A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. NO INJURIES OR MEDICAL INTERVENTION WAS REPORTED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440903 RECIPROCATING SAW ATTACHMENT FOR PEN DRIVE HWE SYNTHES USA 1520481

    Patients

    Seq Age Sex Outcome Treatment
    1