BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AAMI LEVEL 3 SURG HOOD

    MDR report key: 5708762 · Received June 9, 2016

    Report

    Report Number
    0001526350-2016-00060
    Event Type
    Malfunction
    Date Received
    June 9, 2016
    Date of Event
    May 19, 2016
    Report Date
    June 7, 2016
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FYA
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE 00-9900-301-12 TOTALSHIELD SURGICAL HOOD LOT NUMBERS D140833 ARE AN ORIGINAL EQUIPMENT MANUFACTURER (OEM) DEVICE PURCHASED FROM (B)(4). (B)(4) HAS DESIGN AND MANUFACTURING CONTROL. THERE HAVE BEEN A SIGNIFICANT NUMBER OF COMPLAINTS ON THE FACE SHIELD CLARITY ISSUE. A SUPPLIER COMPLAINT INFORMATION REQUEST (SCIR) WAS INITIATED AND FORWARDED TO (B)(4) FOR EACH COMPLAINT. THE RESPONSE HEREIN IS BASED ON THE TEAM INVESTIGATION EFFORT OF (B)(4) (SUPPLIER OF THE FACE SHIELD RAW MATERIAL), (B)(4) (SUPPLIER OF THE SURGICAL HOOD) AND ZIMMER BIOMET. IT WAS DETERMINED THAT THE REPORTED FAULT IS A DESIGN AND MANUFACTURING/INSPECTION ISSUE. CONSEQUENTLY, THE REVIEW OF ANY OF THE DEVICE HISTORY RECORDS (DHR) WAS NOT WARRANTED. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. CONSEQUENTLY, THE INCOMING VISUAL INSPECTION CONFIRMATION OF THE FACE SHIELD CLARITY WAS NOT DETERMINED. HOWEVER, THE MANUFACTURING OF THESE PRODUCTION LOTS SIGNIFY THAT THESE HOODS WERE PRODUCED PRIOR TO THE ENGINEERING CHANGE IN THE FACE SHIELD MATERIAL. THE CUSTOMERS REPORTED EVENTS WERE THAT THE SURGICAL HOOD FACE SHIELDS WERE ¿BLURRY¿. DUE TO THE HISTORY ON THIS PRODUCT AND THE PRODUCTION LOT NUMBERS IT IS MOST LIKELY THAT THESE HOODS DID HAVE A CLARITY ISSUE. THIS REPORTED EVENT WAS CONSIDERED TO BE OUT OF THE BOX EVENTS. THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE FOR THESE REPORTED FAULTS WAS TWO-FOLD. FIRST THE ORIGINAL DRAWINGS AND RAW MATERIAL SPECIFICATION DID NOT DEFINE A GLARE AND OPACITY ACCEPTANCE CRITERIA. WITH THE GLARE AND OPACITY CRITERIA DEFINED IT WAS FOUND THAT THE MANUFACTURING PROCESS WAS NOT CONSISTENT IN PROVIDING ACCEPTABLE FACE SHIELDS. THE ORIGINAL MATERIAL SPECIFICATION AND DESIGN DRAWING DID NOT DEFINE AN ACCEPTANCE REQUIREMENT FOR THE FACE SHIELD MATERIAL. (B)(4) WORKING WITH (B)(4) REVISED THE RAW MATERIAL SPECIFICATION (DEFINES ALL OF THE QUALITY REQUIREMENTS FOR THE FACE SHIELD INCLUDING THE MINIMUM ALLOWANCE OF VISUAL FLAWS AND/OR EMBEDDED PARTICULATE). THE NEW REVISION INCORPORATED DEFINING THE MEASURING METHOD AND MINIMUM GLOSS AND OPACITY REQUIREMENTS. THE PETG PLASTIC RAW MATERIAL MANUFACTURER (B)(4) REVISED THE MANUFACTURING PROCESS FOR ROLLING THE FACE SHIELD MATERIAL. IT WAS DETERMINED THAT CHROME PLATED ROLLERS PROVIDE A MORE CONSISTENT PRODUCT THAN USING TITANIUM OR CERAMIC ROLLERS. THE CHANGE IN THE ROLLERS AND THE INSPECTION METHOD FOR GLOSS AND OPACITY ACCEPTANCE DEFINED IN THE RAW MATERIAL SPECIFICATION WERE ADDED TO THE MANUFACTURING AND TESTING INSTRUCTIONS. RECOMMENDED ACTIONS: ZIMMER BIOMET SURGICAL SHALL REVISE ALL APPLICABLE INTERNAL SPECIFICATIONS, DRAWINGS AND DOCUMENTS TO REFLECT THE REVISION DISCUSSED AND INCORPORATED BY (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON HAD IMPAIRED VISION ON SEVERAL HOODS. THE VIEW WAS SO BAD THAT THE IMPLANT SPECIFICATIONS WERE READ WRONGLY BY THE SURGEON WHICH RESULTED IN OPENING THE WRONG IMPLANT PACKAGE. THE MISTAKE WAS NOTICED BEFORE IMPLANTATION SO ANOTHER IMPLANT WAS USED. SOME SHIELDS IN THE BOX ARE OFTEN BENT WHICH MAKES DONNING IMPOSSIBLE. FURTHERMORE, THE FOLDING OF THE STERILE WRAP IS INCORRECT. ADDITIONAL INFORMATION WAS RECEIVED ON JUN 9, 2016 STATING THAT THE EVENT OCCURRED DURING SURGERY, BUT THERE WAS NO HARM OR INJURY TO THE PATIENT OR OPERATOR. ANOTHER HOOD WAS AVAILABLE FOR USE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON JUN 7, 2016 STATED THAT AN ALTERNATE PRODUCT WAS RETRIEVED FOR USE DURING THE SURGERY WITH A DELAY OF ABOUT 0-15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362684 AAMI LEVEL 3 SURG HOOD SURGICAL HOOD FYA ZIMMER SURGICAL, INC. N/A D140833

    Patients

    Seq Age Sex Outcome Treatment
    1