BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSCILLATING SAW BLADE LINVATEC®/HALL® POWERPRO®

    MDR report key: 7756210 · Received August 7, 2018

    Report

    Report Number
    0002950261-2018-00001
    Event Type
    Malfunction
    Date Received
    August 7, 2018
    Date of Event
    May 16, 2018
    Report Date
    October 11, 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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (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). THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION. UDI: (B)(4). THE DHR REVIEW DID NOT NOTE OF ANY NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD), CHANGE NOTICES (CN), OR ANY OTHER ISSUES WITH MANUFACTURING RELATED TO THE REPORTED EVENT. THE DHR REVIEW FOUND ALL VERIFICATIONS, INSPECTIONS, AND TESTS TO BE SUCCESSFULLY COMPLETED. ON (B)(6) 2018, IT WAS REPORTED FROM (B)(6) THAT A OSCILLATING SAW BLADE LINVATEC®/HALL® POWERPRO® BROKE IN THE ENGINE AT THE FIXATION LEVEL. ON 24 SEPT 2018, A RETURNED PRODUCT INVESTIGATION WAS PERFORMED ON THE OSCILLATING SAW BLADE LINVATEC®/HALL® POWERPRO®. THE PHYSICAL EVALUATION REVEALED THAT THE RETURNED BLADE BROKE AT THE ATTACHMENT POINT. THE RESULTS OF THE RETURNED PRODUCT INVESTIGATION HAVE CONFIRMED THE REPORTED EVENT. WHILE THE RETURNED PRODUCT INVESTIGATION CONFIRMED THAT THE OSCILLATING SAW BLADES LINVATEC®/HALL® POWERPRO® BROKE, IT CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED WHAT ACTUALLY CAUSED THE REPORTED EVENT. THEREFORE, BASED ON THE INFORMATION PROVIDED, A SPECIFIC ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. 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 A SURGERY, THE BLADE HAS BROKEN IN THE ENGINE AT THE FIXATION LEVEL. THERE WAS NO PATIENT HARM AND A DELAY OF 16-30 MINUTES. THEY USED ANOTHER BLADE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599083 OSCILLATING SAW BLADE LINVATEC®/HALL® POWERPRO® BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA SYNVASIVE TECHNOLOGY, INC. 291370

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR