BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 2991995 · Received March 7, 2013

    Report

    Report Number
    8030965-2013-00758
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 6, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A MANUFACTURING AND/OR PRODUCT INVESTIGATION COULD NOT BE PERFORMED AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED PROBLEM COULD NOT BE CONFIRMED OR DUPLICATED. THE UNIT WAS TESTED AND PASSED ALL OPERATIONAL SPECIFICATIONS AND NO PROBLEMS WERE NOTED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS NOT RETURNED FOR FURTHER INVESTIGATION. PLACEHOLDER.

    Description of Event or Problem · 1

    ON (B)(6) 2013, DURING PRE-TEST OF DEVICE, THE PRODUCT WAS GETTING HOT. DEVICE WAS NOT USED IN SURGICAL PROCEDURE. NO PATIENT INVOLVEMENT AND NO HARM TO USER REPORTED.

    Description of Event or Problem · 1

    THIS REPORT IS #1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97697 SMALL BATTERY DRIVE HWE SYNTHES GMBH 002653

    Patients

    Seq Age Sex Outcome Treatment
    1