BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAWS

    MDR report key: 7272478 · Received February 15, 2018

    Report

    Report Number
    0009613350-2018-00246
    Event Type
    Malfunction
    Date Received
    February 15, 2018
    Date of Event
    January 10, 2018
    Report Date
    August 8, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LXH
    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

    DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: DAMAGED DEVICE. EVENT SUMMARY: IT HAS BEEN REPORTED THAT BOTH SIDES OF THE PLASTIC JAWS USED FOR THE STEM EXTRACTION INSTRUMENT ARE WORN OUT DUE TO EXCESSIVE USE. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS VISUAL EXAMINATION: THE JAW SHOWS DEFORMATION, SCRATCHES, CUTS AND WORN OUT PARTS ON ALL SURFACES OF THE DEVICE. ESPECIALLY, THE SURFACE CONNECTING TO THE COMPRESSION SCREW OF THE EXTRACTOR INSTRUMENT IS HIGHLY DAMAGED. THE NOTCH (SLOT) IS COMPLETELY BROKEN OFF AND THE SURFACE CONTAINS MULTIPLE IMPRINTS AND INDENTATIONS. ADDITIONALLY, THE SURFACE CONNECTING TO THE NECK OF THE STEM SHOWS CUTS AND WORN OUT PARTS. REF: 01.00529.103, LOT: 14.984262: THE JAW SHOWS DEFORMATION, SCRATCHES, CUTS AND WORN OUT PARTS ON ALL SURFACES OF THE DEVICE. ESPECIALLY, THE SURFACE CONNECTING TO THE NECK OF THE STEM SHOWS ABRASION AND INDENTATION. BASED ON THIS VISUAL EXAMINATION THE REPORTED EVENT CAN BE CONFIRMED. - MEASUREMENTS: NO MEASUREMENT WAS PERFORMED AS THE DEVICE IS HIGHLY DEFORMED AND BEYOND REPAIR. REFER TO THE VISUAL EXAMINATION. FURTHER THE DHR INDICATES THAT ALL COMPONENTS MET ALL SPECIFICATIONS. - FUNCTIONAL TEST: NO FUNCTIONAL TEST WAS PERFORMED WITH THIS DEVICE AS IT IS HIGHLY DEFORMED AND BEYOND REPAIR. BUT, THE FUNCTIONAL TEST OF A SIMILAR, PREVIOUSLY INVESTIGATED FAILURE PATTERN WAS REVIEWED. IN GENERAL, THE JAW IS PLACED ON A COMPRESSION SCREW WHICH CAN BE TIGHTENED DURING SURGERY TO GRAP THE NECK OF A STEM FOR EXTRACTION. THIS COMPRESSION SCREW HAS A ROUND PLATE AT THE END WHICH IS SUPPOSED TO BE PLACED WITHIN THE CORRESPONDING NOTCH OF THE JAW. NEVERTHELESS, THE VISUAL EXAMINATION OF THE RETURNED JAW SHOWS THAT THE ROUND PLATE WAS MOST LIKELY NOT SLIDED INTO THE NOTCH, BUT WAS PRESSED ONTO THE WALL OF THE NOTCH FROM THE OUTSIDE DURING APPLICATION. REVIEW OF PRODUCT DOCUMENTATION - INSPECTION PLAN: - CHARACTERISTIC NO. 5 FEATURE ¿NUT WIDTH (9 +0.15/+0.1) WITH SCOPE OF TESTING: 100%. MEANS OF INSPECTION: LEHRE. - CHARACTERISTIC NO. 6 FEATURE ¿RADIUS (R6 0.1/0) WITH SCOPE OF TESTING: 100%. MEANS OF INSPECTION: CALIPER. - SURGICAL TECHNIQUE, SECTION "DISASSEMBLY OF THE EXTRACTION INSTRUMENT", PAGE 20, STATES THAT DAMAGED PLASTIC JAWS HAVE TO BE REPLACED. 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 WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. DAMAGED INSTRUMENTS, IMPLANTS, BODY OR WRONG OPERATIONAL STEP DUE TO SURGEON OR OR STAFF UNFAMILIAR WITH INSTRUMENT USAGE AND HANDLING POSSIBLE, AS THE NOTCH OF THE JAW HAS BEEN BROKEN OFF COMPLETELY AND THE SURFACE CONTAINS MANY CUTS AND DENTS. DAMAGED INSTRUMENTS, IMPLANTS, BODY OR WRONG OPERATIONAL STEP DUE TO SURGEON OR OR STAFF UNFAMILIAR WITH INSTRUMENT USAGE AND HANDLING POSSIBLE, AS THE NOTCH OF THE JAW HAS BEEN BROKEN OFF COMPLETELY AND THE SURFACE CONTAINS MULTIPLE CUTS AND DENTS. INSTRUMENT BREAKS OR DEFORMS DUE TO OFF-LABEL / ABNORMAL-USE NOT POSSIBLE AS NOTHING INDICATES THAT THE DEVICE HAS BEEN USED FOR AN OFF-LABEL USE. CONCLUSION SUMMARY BASED ON THE RETURNED PRODUCT AND THE GIVEN INFORMATION THE COMPLAINT COULD BE CONFIRMED. THE VISUAL EXAMINATION AND THE COMPARISON TO A SIMILAR FAILURE PATTERN OF COMPLAINT CMP-0228624 SHOWED THAT THE DEVICE HAS MOST LIKELY NOT BEEN CORRECTLY ASSEMBLED WITH THE COMPRESSION SCREW PRIOR TO USAGE. THE COMPRESSION SCREW HAS A ROUND PLATE AT THE END WHICH IS SUPPOSED TO BE PLACED WITHIN THE CORRESPONDING NOTCH OF THE JAW. THE VISUAL EXAMINATION OF THE RETURNED JAW SUGGESTS THAT THE COMPRESSION SCREW WAS NOT INSERTED INTO THE NOTCH OF THE JAW AS INTENDED, BUT THAT THE ROUND PLATE HAS BEEN PRESSED ONTO THE WALL OF THE NOTCH FROM THE OUTSIDE DURING APPLICATION. THIS CAUSED THE COMPLETE BREAKING-OFF THE NOTCH AND THE DEFORMATION AND INDENTATION OF THE CONNECTING SURFACE. THEREFORE, THE JAW WAS MOST LIKELY NOT CORRECTLY REASSEMBLED AFTER CLEANING / STERILISATION. IN ADDITION, THE MULTIPLE CUTS, DENTS AND INDENTATIONS SUGGEST THAT THE DEVICE WAS USED EXCESSIVELY. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THEREFORE, BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE MISASSEMBLY OF THE COMPRESSION SCREW WITH THE JAW IS THE MOST LIKELY ROOT CAUSE FOR THIS ISSUE. 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 WINTERTHUR AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET WINTERTHUR 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
    117217 JAWS LXH ZIMMER GMBH N/A 16.291707

    Patients

    Seq Age Sex Outcome Treatment
    1 JAWS, ITEM# 01.00529.103, LOT# 14.984262