BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARREL TORNADO BURR 4.0MM 5PK

    MDR report key: 8573829 · Received May 2, 2019

    Report

    Report Number
    1221934-2019-56974
    Event Type
    Malfunction
    Date Received
    May 2, 2019
    Date of Event
    January 1, 2018
    Report Date
    February 4, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HRX
    UDI-DI
    10886705022052
    PMA / PMN Number
    K041824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE IS UNKNOWN. INITIAL REPORTER IS COMPANY REPRESENTATIVE. THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. THE COMPLAINT CAN BE CONFIRMED. THE DEVICE WAS RECEIVED IN THE ORIGINAL PACKAGING, AND A SMALL BLACK PIECE OF PLASTIC WAS OBSERVED TO BE LOOSE INSIDE THE SEALED BLISTER. THE DEVICE WAS REMOVED FROM THE PACKAGING, AND NO SURFACES OF THE DEVICE APPEARED TO BE BROKEN OFF. A MEMBER OF NEW PRODUCT DEVELOPMENT (NPD) WAS CONSULTED FOR FURTHER INSIGHT INTO THIS FAILURE. THE NPD ENGINEER INDICATED THAT THE BLACK HUB OF THE DEVICE MAY RETAIN A PIECE OF FLASHING FROM THE INJECTION MOLDING PROCESS. WHEN THE INNER BLADE IS PRESSED INTO THE HUB OF THE OUTER SHAFT, THE PIECE OF FLASHING MAY BE DISPELLED FROM THE DEVICE. THIS FAILURE MODE IS CURRENTLY BEING EVALUATED. WHEN THE PACKAGING WAS PEELED TO GAIN ACCESS TO THE DEVICE INSIDE, IT WAS OBSERVED THAT THERE WERE LARGE VOIDS AND CHANNEL ACROSS THE STERILE SEAL. THERE WAS NO ADHESIVE OBSERVED IN THE AREA OF THE VOIDS. A MEMBER OF MITEK PACKAGING DEVELOPMENT WAS CONSULTED FOR FURTHER INSIGHT INTO THIS FAILURE. THE PACKAGING ENGINEER INDICATED THAT THIS TYPE OF FAILURE CAN OCCUR WHEN OIL AND ISOPROPYL ALCOHOL MAKES CONTACT WITH THE SEAL ADHESIVE IN COMBINATION WITH BEING HEATED. WHEN THIS HAPPENS, THE SOLUTION CAN DISSOLVE THE SEAL ADHESIVE, THEREFORE CREATING A VOID IN THE STERILE SEAL. THE SHAPE OF THE VOID ON ONE OF THE LONG EDGES WAS WIDEST ALONG THE OUTSIDE EDGE AND GRADUALLY TAPERED INWARD TOWARDS THE INSIDE OF THE BLISTER. GIVEN THIS ATTRIBUTE, IT IS MOST LIKELY THAT THE SOLUTION ORIGINATED FROM OUTSIDE OF THE SEALED PACKAGE AND MIGRATED INWARD. IT IS POSSIBLE THAT THE PACKAGE CAME IN CONTACT WITH AN OIL/ALCOHOL SOLUTION AT THE CUSTOMER FACILITY OR DURING THE RETURN SHIPMENT TO OUR FACILITY FOR PRODUCT INVESTIGATION. THEN, WHEN SUBJECTED TO THE DECONTAMINATION PROCESS HEAT MAY HAVE BEEN GENERATED AND CAUSED THE OIL/ALCOHOL SOLUTION TO HEAT UP AND DEGRADE THE SEALED ADHESIVE THEREFORE IS A POTENTIAL ROOT CAUSE FOR THE COMPROMISED SEAL. HOWEVER, GIVEN THE INFORMATION PROVIDED WE CANNOT DISCERN A DEFINITIVE ROOT CAUSE FOR THE SEAL DEFECT. A DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. A PROCESS DEVIATION WAS INITIATED DURING THE PROCESSING OF THIS LOT, HOWEVER THE PROCESS INVOLVED IN THE DEVIATION IS NOT RELATED TO THE DEFECTS OBSERVED. RELEVANT ACTION HAS BEEN INITIATED TO FURTHER INVESTIGATE THE COMPROMISED SEAL FAILURE. AT THIS POINT, NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TORNADO BURR 4MM WAS DETACHED INSIDE THE PACKAGING. THE THERE WAS NO REPORTED PATIENT HARM AS IT WAS FOUND PRE-OPERATIVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369633 BARREL TORNADO BURR 4.0MM 5PK  ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE HRX DEPUY MITEK LLC US 283489 M1801007 10886705022052

    Patients

    Seq Age Sex Outcome Treatment
    1