BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSCILLATING SAW BLADE LINVATEC®/HALL® POWERPRO®

    MDR report key: 6893533 · Received September 26, 2017

    Report

    Report Number
    0002950261-2017-00016
    Event Type
    Malfunction
    Date Received
    September 26, 2017
    Date of Event
    September 21, 2017
    Report Date
    November 8, 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

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). REVIEW OF THE DEVICE HISTORY RECORD FOR (B)(4), LOT NUMBER 264323, 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. 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 THE SAW BLADE BROKE DURING THE FEMORAL HEAD CUT. X-RAYS WERE DONE TO SEE IF THE BROKEN PIECE WAS IN THE PATIENT. THEY FINALLY FOUND IT AT THE END OF THE SURGERY, NOT IN THE PATIENT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673971 OSCILLATING SAW BLADE LINVATEC®/HALL® POWERPRO® OSCILLATING SURGICAL SAW BLADE, SINGLE-USE GFA SYNVASIVE TECHNOLOGY, INC. N/A 264323

    Patients

    Seq Age Sex Outcome Treatment
    1