BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSCILLATING SAW BLADE AESCULAP®

    MDR report key: 6951267 · Received October 16, 2017

    Report

    Report Number
    0002950261-2017-00017
    Event Type
    Malfunction
    Date Received
    October 16, 2017
    Date of Event
    May 18, 2017
    Report Date
    October 16, 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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS BEING REPORTED BY ZIMMER BIOMET AS (B)(4). REVIEW OF THE DEVICE HISTORY RECORD FOR (B)(4), LOT NUMBER 64065, IDENTIFIED NO RELEVANT DEVIATIONS OR ANOMALIES. PRODUCT EXAMINATION COULD NOT BE PERFORMED AS THERE WAS NO PRODUCT RETURNED FOR THIS COMPLAINT. THIS COMPLAINT CANNOT BE CONFIRMED. BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION, 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. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MDR SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MFR NUMBER, 0001526350-2017-00381 AND IS INSTEAD IS BEING FILED UNDER THIS MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAW BLADE BROKE DURING USE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731211 OSCILLATING SAW BLADE AESCULAP® BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA SYNVASIVE TECHNOLOGY, INC. N/A 64065

    Patients

    Seq Age Sex Outcome Treatment
    1