BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHISEL BLADE W/10

    MDR report key: 3130247 · Received May 24, 2013

    Report

    Report Number
    8030965-2013-02423
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Report Date
    April 27, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE HAS BEEN RETURNED. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION HAS SHOWN THAT A PIECE OF THE EDGE IS INDEED BROKEN OFF AS WELL AS BADLY DAMAGED. WE ASSUME THAT THE BLADE CAME IN CONTACT WITH A METALLIC PART. THE SURFACE OF THE BROKEN/DAMAGED BLADE IS HOMOGENEOUS WHICH INDICATES CONFORMITY TO THE SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. PLACEHOLDER.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) INDICATES A HOSPITAL IN (B)(6) REPORTED: CHISEL BLADE IS BROKEN DURING USES. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230876 CHISEL BLADE W/10 FZO SYNTHES GMBH T984314

    Patients

    Seq Age Sex Outcome Treatment
    1