BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CBS CSK15MM AO CAN1.4MM DPCBS4

    MDR report key: 6960857 · Received October 19, 2017

    Report

    Report Number
    0009613350-2017-01480
    Event Type
    Malfunction
    Date Received
    October 19, 2017
    Date of Event
    October 6, 2017
    Report Date
    May 30, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    HWW
    PMA / PMN Number
    PN/A
    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 HAS FRACTURED DURING USE. REVIEW OF RECEIVED DATA: THREE PICTURES OF THE INSTRUMENT AND ONE PICTURE FROM THE LABEL HAVE BEEN RECEIVED. HOWEVER, NO DEFECT OF THE INSTRUMENT COULD BE DETECTED ON THE PICTURES. DEVICES ANALYSIS - VISUAL EXAMINATION: THE INSTRUMENT HAS BEEN RETURNED FOR AN INVESTIGATION. THE TIP HAS FOUR CRACKS AND IS ENLARGED. MOREOVER, ANOTHER INSTRUMENT OF THE SAME LOT NUMBER HAS BEEN RETURNED FOR ANOTHER COMPLAINT (CMP-0326586). THE MATERIAL OF THIS INSTRUMENT HAS BEEN ANALYZED BY ZIMMER BIOMET'S RESEARCH DEPARTMENT. - HARDNESS TEST: THE HARDNESS HAS BEEN DETERMINED TO BE IN AVERAGE 440 HV10, WHICH REPRESENTS A VALUE OF 44.5 HRC. THE SPECIFICATION IS 48-54 HRC. THEREFORE THE HARDNESS OF THE INSTRUMENT IS NOT ACCORDING TO SPECIFICATIONS - CHEMICAL ANALYSIS: IT WAS FOUND THAT THE CARBON CONTENT IS WITH A VALUE OF 0.0359% UNDERNEATH THE SPECIFIED VALUE OF 0.26 TO 0.35 PER CENT BY WEIGHT. ADDITIONALLY, WITH THE EDX-ANALYSIS CU AND NI HAVE BEEN FOUND, WHICH ARE NOT PART OF MATERIAL 1.4028. - STRUCTURAL CONDITIONS: THE MICROSTRUCTURE DOES NOT REVEAL THE MARTENSITIC STRUCTURE AS EXPECTED FROM MATERIAL 1.4028 WHICH HAS BEEN TREATED. RESULT: THIS INSTRUMENT OF THE SAME LOT NUMBER AS THE ONE REPORTED IN THIS COMPLAINT HAS NOT BEEN MANUFACTURED WITH MATERIAL 1.4028. MORE LIKELY, THE MATERIAL RESEMBLES 1.4542. ADDITIONALLY, THE DIMENSION OF THE CANNULATION OF THE RETURNED INSTRUMENT OF THE SAME LOT HAS BEEN MEASURED WITHIN CMP-0326586. IT WAS FOUND TO BE LARGER THEN SPECIFIED IN THE PRODUCT DRAWING. NO ADDITIONAL MATERIAL TEST HAS BEEN PERFORMED FOR THIS PRODUCT, AS THE SUPPLIER RISA HAS ALREADY CONFIRMED THAT FOR THE PRODUCTION OF THIS LOT, MATERIAL 1.4542 HAS BEEN USED. REVIEW OF PRODUCT DOCUMENTATION - DEVICE HISTORY RECORDS (DHR): 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 SALES OF THESE IMPLANTS HAVE BEEN DETERMINED. IT WAS FOUND THAT 1760 SCREWS HAVE BEEN SOLD AND IMPLANTED. THEREFORE IT CAN BE CONCLUDED, THAT THE INSTRUMENTS OF REF 503004352 HAVE BEEN USED AT LEAST 1760 TIMES. THIS LEADS TO A COMPLAINT RATE OF 2/1760=0.114%. 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 WAS FOUND TO BE 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. - DETERIORATION IN FUNCTION DUE TO WRONG MAINTENANCE => POSSIBLE, AS A DETERIORATION IN FUNCTION AS A RESULT OF REPEATED USE CANNOT BE EXCLUDED. - 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 => POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. CONCLUSION SUMMARY THE INSTRUMENT HAS BEEN RETURNED FOR AN INVESTIGATION. IT CAN BE CONFIRMED THAT THE TIP IS CRACKED. THE ANALYSIS OF THE MATERIAL OF ANOTHER INSTRUMENT FROM THE SAME LOT NUMBER SHOWED THAT THE MATERIAL WAS NOT ACCORDING TO SPECIFICATION. THE PROPERTIES, WHICH HAVE BEEN DETERMINED, RESEMBLE MATERIAL 1.4542 INSTEAD OF 1.4028. SUBSEQUENTLY, THE SUPPLIER HAD CONFIRMED THAT FOR MANUFACTURING THE INSTRUMENTS OF THIS LOT NUMBER, MATERIAL 1.4542 HAS BEEN USED. MOREOVER, THE DIMENSION OF THE CANNULATION WAS FOUND TO BE NOT ACCORDING TO THE SPECIFICATION DEFINED IN THE DRAWING. 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 (B)(6) 2018. ZIMMER GMBH CONSIDERS THE CASE AT HAND AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS CMP-0335298.

    Additional Manufacturer Narrative · 1

    PHOTOGRAPHS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE YET THE DEVICE, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. 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. 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 (B)(6) 2017 THE COUNTERSINK (CBS CSK15MM AO CAN1.4MM DPCBS4) GOT BROKEN DURING USAGE. IT WAS ALSO REPORTED THAT SURGERY WAS EXTENDED APPROXIMATELY FOR 5 MINUTES AND SURGERY WAS COMPLETED WITH ANOTHER DEVICE. 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
    741394 CBS CSK15MM AO CAN1.4MM DPCBS4 UNKNOWN HWW ZIMMER GMBH N/A 14935

    Patients

    Seq Age Sex Outcome Treatment
    1