BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAWS

    MDR report key: 7272479 · Received February 15, 2018

    Report

    Report Number
    0009613350-2018-00247
    Event Type
    Malfunction
    Date Received
    February 15, 2018
    Date of Event
    January 10, 2018
    Report Date
    August 8, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    HWB
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY INVESTIGATION RESULT. ADDITIONAL AND CORRECTED INFORMATION ARE FILLED IN THE FOLLOWING FIELDS: ADDITIONAL: D10. CORRECTION: B4 - G4 - G7 - H6 - H10. DHR REVIEW: THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: A TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: BROKEN MECHANISM. TRIGGER FOR AN ISSUE EVALUATION IS MET. ISSUE EVALUATION (B)(4) HAS ALREADY BEEN INITIATED. EVENT DESCRIPTION: IT WAS REPORTED THAT THE RASP HAS DIFFICULTY COMING OFF THE RASP HANDLE. JAWS WONT OPEN WIDE ENOUGH TO LET GO OF RASP. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED DEVICE ANALYSIS: -VISUAL EXAMINATION: THE MIS RASP HANDLE HAS BEEN RETURNED FOR AN INVESTIGATION. THE LOCKING LEVER IS SITTING CORRECTLY IN THE RASP HANDLE. THE MECHANISM IS FUNCTIONAL. ADDITIONALLY THERE ARE SEVERAL SIGNS OF USAGE VISIBLE. NO OTHER CONSPICUOUSNESS FOUND. SEE PICTURES ATTACHED -FUNCTIONAL TEST: A FUNCTIONAL TEST HAS BEEN PERFORMED WITH A RASP OF REF AND LOT. THE OPENING AND CLOSING OF THE MECHANISM OF THE RASP HANDLE WORKED WITHOUT ISSUES. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING RMW: - INSTRUMENT BREAKS, DEFORMS, DIVERGES IMPAIRING ITS FUNCTION DUE TO INADEQUATE DESIGN FOR INTENDED PERFORMANCE. NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - INSTRUMENT BREAKS, DEFORMS, DIVERGES IMPAIRING ITS FUNCTION DUE TO MECHANICAL PROPERTIES OF MATERIAL INSUFFICIENT. NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - INSTRUMENT CANNOT BE USED WITH THE MATING INSTRUMENT OR MATING IMPLANT AS INTENDED DUE TO FAILURE OF INSTRUMENT MATING CONDITION => POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. - DAMAGED INSTRUMENTS, IMPLANTS, BODY OR WRONG OPERATIONAL STEP DUE TO SURGEON OR STAFF UNFAMILIAR WITH INSTRUMENT USAGE AND HANDLING => POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. - DAMAGED INSTRUMENTS, IMPLANTS, BODY OR WRONG OPERATIONAL STEP DUE TO SURGEON OR STAFF UNFAMILIAR WITH INSTRUMENT USAGE AND HANDLING => POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. - INSTRUMENT BREAKS OR DEFORMS DUE TO OFF-LABEL / ABNORMAL-USE. NOT POSSIBLE -> INSTRUMENT DOES NOT SHOW SIGNS OF AN OFF-LABEL USE. - INSTRUMENT CANNOT BE USED WITH THE CONNECTED INSTRUMENT AS INTENDED DUE TO FAILURE OF INSTRUMENT ASSEMBLY CONDITION =>POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. CONCLUSION: THE MIS RASP HANDLE HAS BEEN RETURNED FOR AN INVESTIGATION. THE LOCKING LEVER IS SITTING CORRECTLY IN THE RASP HANDLE. THE MECHANISM WAS DETERMINED TO BE FUNCTIONAL. IT MIGHT BE POSSIBLE THAT SOFT TISSUE OR BLOOD PREVENTED THE MECHANISM TO OPEN DURING APPLICATION. HOWEVER, BASED ON THE AVAILABLE INFORMATION, NO EXACT ROOT CAUSE COULD BE DETERMINED AND THE REPORTED EVENT COULD NOT BE RECREATED. BASED ON THE AVAILABLE INFORMATION FURTHER INVESTIGATION HAS BEEN INITIATED TO DETERMINE THE NECESSITY OF POTENTIAL CORRECTIVE AND/OR PREVENTIVE ACTIONS. ACCORDING TO THE RESULTS OF THE INVESTIGATION THE CALCULATED COMPLAINT RATE IS WITHIN ACCEPTABLE LIMITS. ACCORDING TO THE RESULTS OF THE SYSTEMATIC ASSESSMENT; THE ISSUE DOES NOT INDICATE TO BE DESIGN RELATED AND DOES NOT APPEAR TO BE SYSTEMATIC. 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).

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES. THE MANUFACTURER DID NOT RECEIVE THE DEVICE YET, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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 BLACK PLASTIC PIECES FROM THE CLS EXTRACTOR ARE WORN OUT FROM EXCESSIVE USE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119224 JAWS HWB ZIMMER GMBH N/A 14.984262

    Patients

    Seq Age Sex Outcome Treatment
    1 JAWS, ITEM# 01.00529.103, LOT# 16.291707