BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSCILLATING SAW BLADE CUTTING

    MDR report key: 7019952 · Received November 10, 2017

    Report

    Report Number
    0002950261-2017-00020
    Event Type
    Malfunction
    Date Received
    November 10, 2017
    Date of Event
    October 11, 2017
    Report Date
    February 8, 2018
    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
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OSCILLATING SAW BLADE CUTTING 90 MM L X 20 MM W X 1.27 MM THICK FITS: ZIMMER®/SYNTHES®. PRODUCT HAS BEEN NOT RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION WILL BEGIN ONCE PRODUCT IS RECEIVED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS RECORDED WITH ZIMMER BIOMET UNDER (B)(4). THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION. REVIEW OF THE DEVICE HISTORY RECORD FOR 20090127AGC, LOT NUMBER 256825, IDENTIFIED NO RELEVANT DEVIATIONS OR ANOMALIES. A REVIEW USING THE P/N OF THIS COMPLAINT AND ALSO BASED UPON OPEN AND CLOSED COMPLAINTS AND THE KEYWORD SEARCH USING THE CHARACTER STRING ¿STERILE¿ RESULTED IN 1 COMPLAINT. A REVIEW USING THE CRITERIA OF P/N AND COMPLAINT CATEGORY OF THIS COMPLAINT AND ALSO BASED UPON OPEN AND CLOSED COMPLAINTS AND THE KEYWORD SEARCH USING THE CHARACTER STRING ¿STERILE¿ AND SORTED BY MANUFACTURER DATE WAS PERFORMED. THIS REVIEW RESULTED IN THE HIGHEST OCCURRENCE FOR A GIVEN MANUFACTURE DATE WAS 1. REVIEWING THE COMPLAINTS FOR THE LOT NUMBER 256825 SHOWS 1 COMPLAINT FOR THIS PART AND LOT NUMBER. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE SPECIFICALLY DETERMINED WITH THE PROVIDED INFORMATION AS NO PRODUCT WAS RETURNED FOR THIS COMPLAINT. 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 THE PACKAGING WAS OPEN. THUS, THE ITEMS THAT SHOULD BE STERILE WERE NO LONGER STERILE UPON THE CUSTOMER RECEIVING THESE ITEMS THE EVENT OCCURRED PRIOR TO SURGERY AND UPON RECEIVAL INSPECTION. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801776 OSCILLATING SAW BLADE CUTTING BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA SYNVASIVE TECHNOLOGY, INC. N/A 256825

    Patients

    Seq Age Sex Outcome Treatment
    1