BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROCATING SAW BLADE

    MDR report key: 6793502 · Received August 14, 2017

    Report

    Report Number
    0001526350-2017-00510
    Event Type
    Malfunction
    Date Received
    August 14, 2017
    Date of Event
    July 14, 2017
    Report Date
    September 15, 2017
    Manufacturer
    SYNVASIVE TECHNOLOGY, INC.
    Product Code
    GFA
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MDR SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MFR NUMBER. THIS EVENT WILL BE REPORTED ON UNDER (B)(6).

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS BEING REPORTED BY ZIMMER BIOMET AS (B)(4). THE PRODUCT HAS NOT BEEN RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. HOWEVER, THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY THE SAW BLADES TREMBLED ABNORMALLY WHEN BEING USED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572463 RECIPROCATING SAW BLADE BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA SYNVASIVE TECHNOLOGY, INC. N/A 254669

    Patients

    Seq Age Sex Outcome Treatment
    1