BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN WEBER PLUG

    MDR report key: 8989639 · Received September 11, 2019

    Report

    Report Number
    0009613350-2019-00558
    Event Type
    Injury
    Date Received
    September 11, 2019
    Report Date
    April 24, 2020
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW, INCLUDING PART AND LOT SPECIFIC INVESTIGATION, COULD NOT BE PERFORMED AS THE ITEM NUMBER IS UNKNOWN. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT DURING A THR THE CANAL FOR THE WEBER PLUG WAS A LOOSE 12 AND A 12MM PLUG WAS USED. ON THE BOX THIS SHOULD BE A SIZE 2.5 BUT ON THE CONVERSION CHART THIS IS A SIZE 5 (19MM). THE PLUG GOT STUCK HALFWAY DOWN, SO IT HAD TO BE DRILLED AND THEN POKED DOWN. NO REFERENCE AND LOT NUMBERS HAVE BEEN REPORTED. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS WERE RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. IT WAS REPORTED THAT IT HAS BEEN DISCARDED. REVIEW OF PRODUCT DOCUMENTATION THIS DEVICE IS INTENDED FOR TREATMENT. DUE TO A CE CERTIFICATION ISSUE ALLEN PLUGS ARE CURRENTLY UNAVAILABLE AND WEBER PLUGS WERE OFFERED AS ALTERNATIVE IN A FIELD COMMUNICATION. THE COMPATIBILITY MATRIX ON ZB WEBSITE (WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM) DOES NOT INDICATE THAT WEBER PLUGS CAN BE USED FOR ALLEN SYSTEM. BOTH SURGICAL TECHNIQUES DESCRIBE THE USE / MEASURING OF THE CORRESPONDING PLUG IN A COMPREHENSIVE WAY. DHR REVIEW: THE QUALITY RECORDS COULD NOT BE PERFORMED AS NO LOT NUMBER WAS REPORTED. THE MISSING DEVICE INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE. AT ZIMMER GMBH ALL MEDICAL DEVICES PRIOR RELEASE TO MARKET UNDERGO SEVERAL QUALITY INSPECTIONS AS DEFINED IN OUR QUALITY PROCEDURES. OUR QUALITY INSPECTION- AND DEVIATION PROCEDURES ENSURE THAT ONLY PRODUCTS FULFILLING THE SPECIFICATION ARE SOLD. THESE PROCEDURES ARE PART OF THE OVERALL QUALITY MANAGEMENT SYSTEM AT ZIMMER GMBH AND GET REGULARLY AUDITED BY OUR NOTIFIED BODY, COMPETENT AUTHORITIES AND INTERNAL AND EXTERNAL AUDITORS. THUS, FOR ALL PRODUCTS SOLD TO THE MARKET CAN BE ASSUMED HAVING A COMPLETE AND CORRECT DHR. CONCLUSION SUMMARY: IT WAS REPORTED THAT DURING A THR, A 12MM WEBER PLUG WAS USED. ON THE BOX THIS SHOULD BE A SIZE 2.5 BUT ON THE CONVERSION CHART THIS IS A SIZE 5 (19MM). THE PLUG GOT STUCK HALFWAY DOWN, SO IT HAD TO BE DRILLED AND THEN POKED DOWN. AS NO FURTHER INFORMATION WAS PROVIDED, IT IS UNCLEAR IF THE BOX WAS LABELED INCORRECTLY, IF THE INCORRECT SIZE WAS RECEIVED OR IF THE CONVERSION CHART WAS INCORRECT. AS THE CONVERSION CHART WAS MENTIONED IT IS ASSUMED THAT IN THIS CASE A WEBER PLUG WAS USED AS AN ALTERNATIVE FOR THE ALLEN PLUG. DUE TO A CE CERTIFICATION ISSUE ALLEN PLUGS ARE CURRENTLY UNAVAILABLE AND WEBER PLUGS WERE OFFERED AS ALTERNATIVE IN A FIELD COMMUNICATION. BASED ON THE REPORTED EVENT IT IS ASSUMED THAT A WEBER PLUG SIZE 2.5 WAS USED INSTEAD OF A 12 MM ALLEN PLUG. NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS WERE RECEIVED AND NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. THE QUALITY RECORDS COULD NOT BE REVIEWED AS NO ITEM NOR LOT NUMBER WAS REPORTED. THE LIMITED INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). BASED ON THE AVAILABLE INFORMATION THE INVESTIGATION IS VERY LIMITED AND ONLY ASSUMPTIONS CAN BE MADE. THEREFORE, WE ARE NOT ABLE TO IDENTIFY AN EXACT ROOT CAUSE FOR THIS ISSUE. IT IS ASSUMED THAT THE REPORTED EVENT COULD POSSIBLY BE RELATED TO THE USE OF WEBER PLUGS AS AN ALTERNATIVE FOR THE ALLEN PLUG AND ITS FIELD COMMUNICATION INCLUDING THE CONVERSION CHART. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    NO EVENT UPDATE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. AN E-MAIL REQUESTING THE FOLLOWING ADDITIONAL INFORMATION WAS SENT ON SEPTEMBER 06, 2019 TO THE APPROPRIATE REPRESENTATIVES. PLEASE CONFIRM WHETHER OR NOT THIS WAS A REVISION SURGERY. IF IT WAS A REVISION SURGERY, WERE ZIMMER BIOMET PRODUCTS REVISED? WILL THE PACKAGING AND LABELING FOR THE DEVICE BE RETURNED? IF NOT, ARE PHOTOS OF THE BOX, OR DEVICE AVAILABLE? PLEASE CLARIFY IF THE BOX WAS LABELED INCORRECTLY, IF THE INCORRECT SIZE WAS RECEIVED, OR IF THE CONVERSION CHART WAS INCORRECT. FOR EXAMPLE, WAS THE BOX LABELED CORRECTLY, BUT THE SIZE RECEIVED DID NOT MATCH? WAS THERE A SURGICAL DELAY? IF YES, HOW LONG OF A DELAY? IMMEDIATE POST-OP, INTERMEDIATE AND PRE-REVISION X-RAYS (AS APPLICABLE). PLEASE INCLUDE THE DATE OF THE X-RAYS AND INDICATE WHETHER OR NOT THEY ARE POST-OP, INTERMEDIATE, OR PRE-REVISION X-RAYS. RESULTS OF X-RAYS/ RADIOLOGY REPORT. OPERATIVE NOTES. INVOICES FOR THE INITIAL SURGERY. PART AND LOT IDENTIFICATION FOR THE PLUG AND THE LISTING OF ALL PRODUCTS IMPLANTED DURING THE INITIAL SURGERY¿ ITEM/LOT INFORMATION WITH APPLICABLE DATES. SURGEON INFORMATION. PATIENT INFORMATION ¿ PATIENT NAME. GENDER.. DATE OF BIRTH OR AGE. HEIGHT. WEIGHT. ACTIVITY LEVEL. RACE. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY ON AN UNKNOWN DATE THE USED UNKNOWN WEBER PLUG HAD SIZE 2.5 ON THE BOX BUT ON THE CONVERSION CHART THIS IS A SIZE 5. THE WEBER PLUG THEN STUCK HALFWAY DOWN THE FEMUR. THE FEMUR HAD TO BE DRILLED AND THEN THE PLUG HAS BEEN POKE DOWN AND "ON TABLE X-RAYS" HAVE BEEN MADE. NOTE: ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789138 UNKNOWN WEBER PLUG UNKNOWN KWA ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention