BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROCATING SAW BLADE ZIMMER® UNIVERSAL POWER SYSTEMS

    MDR report key: 6866987 · Received September 14, 2017

    Report

    Report Number
    0002950261-2017-00007
    Event Type
    Malfunction
    Date Received
    September 14, 2017
    Date of Event
    July 14, 2017
    Report Date
    September 14, 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

    (B)(6). REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE LOT NUMBER WAS MISREPORTED FOR THIS COMPLAINT. PRODUCT EXAMINATION COULD NOT BE PERFORMED AS THERE WAS NO PRODUCT RETURNED FOR THIS COMPLAINT. THIS COMPLAINT CANNOT BE CONFIRMED. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE SPECIFICALLY DETERMINED WITH THE PROVIDED INFORMATION. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS.

    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
    644029 RECIPROCATING SAW BLADE ZIMMER® UNIVERSAL POWER SYSTEMS BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA SYNVASIVE TECHNOLOGY, INC. N/A 254669

    Patients

    Seq Age Sex Outcome Treatment
    1