BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVECARE +SFT SYSTEM WARNING:

    MDR report key: 8915765 · Received August 21, 2019

    Report

    Report Number
    0001526350-2019-00675
    Event Type
    Malfunction
    Date Received
    August 21, 2019
    Date of Event
    July 28, 2019
    Report Date
    October 14, 2019
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    JOW
    PMA / PMN Number
    K151377
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED UNDER ZIMMER BIOMET COMPLAINT NUMBER (B)(4). D4 - UDI# - (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) AND A COMPLAINT HISTORY REVIEW WILL NOT BE COMPLETED FOR LIMITED INVESTIGATION COMPLAINTS. ON (B)(6) 2019, IT WAS REPORTED THAT THE DEVICE HAD SMOKE ODOR. WHILE EVALUATING THE DEVICE SERVICE TECHNICIAN WAS NOT ABLE TO DUPLICATE THE CONCERN OF REPORTED EVENT. THE SERVICE TECHNICIAN THEN REPLACED TWIST LOCK (405K602000) AND CONFIRMED THAT THE DEVICE WAS FUNCTIONING AS INTENDED. SERVICE TECHNICIAN WAS NOT ABLE TO REPRODUCE THE REPORTED ISSUE WITH THE DEVICE DURING EVALUATION. THEREFORE, BASED ON THE INFORMATION PROVIDED, A SPECIFIC ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. THE INVESTIGATION IS BASED ON THE INFORMATION THAT IS PROVIDED INITIALLY AND ANY INFORMATION THAT IS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD A CIGARETTE SMOKE SMELL TO IT. THE EVENT OCCURRED PRIOR TO GIVING IT OUT TO A PATIENT. THERE WAS NO HARM/INJURY. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE PRODUCT CODE - JOW. (B)(4). THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD SMOKE ODOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712552 ACTIVECARE +SFT SYSTEM WARNING: SLEEVE, LIMB, COMPRESSIBLE JOW ZIMMER SURGICAL, INC. N/A 63962193

    Patients

    Seq Age Sex Outcome Treatment
    1