BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CBS 4.0 COUNTERSINK, CANNULATED, 15MM STOP, AO

    MDR report key: 7120339 · Received December 15, 2017

    Report

    Report Number
    0009613350-2017-01773
    Event Type
    Malfunction
    Date Received
    December 15, 2017
    Date of Event
    September 11, 2017
    Report Date
    May 30, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    HWW
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. TREND ANALYSIS: A TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: TIP OF INSTRUMENT DAMAGED. EVENT DESCRIPTION: IT WAS REPORTED THAT THE TIP OF THE REAMER GOT DAMAGED DURING USE. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED DEVICES ANALYSIS - VISUAL EXAMINATION: THE INSTRUMENT HAS BEEN RETURNED FOR AN INVESTIGATION. THE TIP HAS FOUR CRACKS AND IS ENLARGED. THE MATERIAL OF THE INSTRUMENT HAS BEEN ANALYZED BY ZIMMER BIOMET'S RESEARCH DEPARTMENT. - (B)(4). - MEASUREMENT: THE CANNULATION OF THE RETURNED INSTRUMENT HAS BEEN MEASURED USING TEST PINS. IT WAS FOUND THAT THE TEST PIN WITH A DIAMETER OF 1.5MM COULD BE INSERTED INTO THE CANNULATION WITHOUT ANY RESISTANCE. THE TEST PIN WITH A DIAMETER IF 1.6MM SHOWED SOME RESISTANCE, BUT COULD STILL BE INSERTED INTO THE CANNULATION. THE DIMENSION OF THE CANNULATION IS SPECIFIED TO BE Ø1.4 +0.1/0 MM. REVIEW OF PRODUCT DOCUMENTATION - DEVICE HISTORY RECORDS: THE DHR FOR LOT 14935 HAS BEEN REVIEWED. 5 OF THE 14 INSTRUMENTS HAVE BEEN INSPECTED ACCORDING TO THE DRAWING AND NO FAILURE HAS BEEN FOUND. - A PRODUCT HISTORY REVIEW HAS BEEN PERFORMED. ONE ADDITIONAL SIMILAR INVESTIGATED EVENT FOR THE LOT NUMBER 14935 HAS BEEN FOUND. FURTHER, NO ADDITIONAL COMPLAINTS FOR THIS PART NUMBER HAS BEEN REPORTED. THE SCOPE OF IMPLANTS (SCREWS) FOR WHICH THIS INSTRUMENT WITH REF 503004352 IS USED AND THE SALE OF THESE IMPLANTS HAVE BEEN DETERMINED. IT WAS FOUND THAT (B)(4) SCREWS HAVE BEEN SOLD AND IMPLANTED. THEREFORE IT CAN BE CONCLUDED, THAT THE INSTRUMENTS OF REF 503004352 HAVE BEEN USED AT LEAST (B)(4) TIMES. THIS LEADS TO A COMPLAINT RATE OF (B)(4). ROOT CAUSE ANALYSIS ROOT CAUSE DETERMINATION USING RMW: - BREAKAGE OF INSTRUMENT DUE TO INADEQUATE DESIGN FOR INTENDED PERFORMANCE => POSSIBLE, AS THE FRACTURE OF THE INSTRUMENT MIGHT BE DUE TO LACK OF ADEQUATE STRENGTH AS THE MATERIAL IS NOT ACCORDING TO SPECIFICATION. - DEVICE NOT READY TO BE USED DUE TO CHEMICAL / GALVANIC / CREVICE CORROSION OF MATERIAL, DISCOLOURATION NOT POSSIBLE -> THE RETURNED INSTRUMENT SHOWS NO SIGNS OF CORROSION. - MALFUNCTION, INSUFFICIENT DEVICE PERFORMANCE OR DURABILITY DUE TO 1) USER´S DISREGARD OF MANUFACTURER´S RECOMMENDATION 2) USE ERROR (SLIPS,LAPSES, MISTAKES, REASONABLY FORESEEABLE MISUSE) 3) ABNORMAL USE BEYOND RISK CONTROL => POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. - FAILURE OF SURGERY DUE TO USE OF THE DEVICE NOT COMPLIANT WITH DEFINED INDICATIONS => POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. - FAILURE OF SURGERY DUE TO WRONG SELECTION OF COMPONENTS OR USE IN COMBINATION WITH DEVICE OUTSIDE THE SYSTEMS => POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. - DYSFUNCTIONALITY / MALFUNCTION OF DEFECTIVE DEVICES AND INSTRUMENTS DUE TO MISHANDLING OF DEVICE BY USER NOT POSSIBLE -> THE RETURNED INSTRUMENT DOES NOT SHOW ANY SIGNS OF MISHANDLING BY THE USER. CONCLUSION SUMMARY THE INSTRUMENT HAS BEEN RETURNED FOR AN INVESTIGATION. IT CAN BE CONFIRMED THAT THE TIP IS CRACKED. THE ANALYSIS OF THE MATERIAL SHOWED THAT IT IS NOT ACCORDING TO SPECIFICATION. (B)(4). MOREOVER, THE DIMENSION OF THE CANNULATION WAS FOUND TO BE NOT ACCORDING TO THE SPECIFICATION DEFINED IN THE DRAWING. THE DIFFERENT MATERIAL PROPERTIES COULD HAVE LED TO THE BREAKAGE OF THE THIN-WALLED TIP OF THE INSTRUMENT. HOWEVER, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE AVAILABLE INFORMATION FURTHER INVESTIGATION HAS BEEN PERFORMED AND A VOLUNTARY MEDICAL DEVICE FIELD ACTION HAS BEEN STARTED TO REMOVE THE REMAINING INSTRUMENTS WITH THE AFFECTED LOTNUMBERS IN THE MARKET. IT WAS FOUND THAT ACCORDING TO THE SUPPLIER RISA THE CHANGE IN MATERIAL TO 1.4542 HAS BEEN COMMUNICATED WITH NORMED. AN HEALTH HAZARD EVALUATION HAS BEEN PERFORMED. IT WAS DETERMINED THAT THE USED MATERIAL IS NOT SUITABLE FOR THE INTENDED USE OF THE DEVICE. THE HIGHEST SEVERITY WAS ASSESSED: FRAGMENTS OF THE BROKEN INSTRUMENT COULD REMAIN IN SITU AND CAUSE TISSUE IRRITATION. IF ADDITIONALLY NO REPLACEMENT DEVICE IS AVAILABLE, THE SCREW CANNOT BE FULLY SET INTO THE BONE. THEREFORE THE NECESSITY OF INITIATING A FIELD ACTION WAS DETERMINED. FIELD ACTION FA 2018-05 WAS INITIATED ON MAY 09, 2018. ZIMMER GMBH CONSIDERS THE CASE AT HAND AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    PHOTOGRAPHS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS PENDING. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2017 THE TIP OF THE REAMER: CBS 4.0 COUNTERSINK, CANNULATED, 15MM STOP, AO FRACTURED. THE SURGERY WAS COMPLETED WITH ANOTHER REAMER. NOTES: THE IMPLANTATION AND EXPLANTATION DATES ARE LEFT EMPTY AS THE DEVICE INVOLVED IN THIS COMPLAINT IS AN INSTRUMENT. HENCE, NO EXPIRATION DATE IS CAPTURED, FOR THE SAME REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903063 CBS 4.0 COUNTERSINK, CANNULATED, 15MM STOP, AO N/A HWW ZIMMER GMBH N/A 14935

    Patients

    Seq Age Sex Outcome Treatment
    1