BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR WITH SLIDING HAMMER

    MDR report key: 8141071 · Received December 7, 2018

    Report

    Report Number
    0009613350-2018-01188
    Event Type
    Malfunction
    Date Received
    December 7, 2018
    Date of Event
    November 8, 2018
    Report Date
    February 21, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    HWA
    UDI-DI
    00889024288669
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: DAMAGED THREADS REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT THE SURGEON TRIED TO EXTRACT A VERY WELL, CEMENTLESS, IMPLANTED AVENIR STEM WITH THE AVENIR EXTRACTOR INSTRUMENT. DURING THE REMOVAL TWO EXTRACTORS WERE DAMAGED AT THE THREAD OF THE DISTAL INSTRUMENT COMPONENT. ALL PIECES WERE RETRIEVED. NO DELAY OF SURGERY AND NO HARM TO PATIENT. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, INTRAOPERATIVE PICTURES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DUE TO PATIENT PRIVACY POLICY NO PATIENT DATA WILL BE AVAILABLE. DEVICES ANALYSIS: VISUAL EXAMINATION: AVENIR EXTRACTOR WITH SLIDING HAMMER REF: 01.06808.300, LOT: 4023553: THE EXTRACTOR INSTRUMENT WAS RECEIVED IN DISASSEMBLED STATE (THREE SEPARATE PIECES). NO CONSPICUOUSNESS COULD BE IDENTIFIED ON THE SLIDING HAMMER AND ON THE PROXIMAL COMPONENT OF THE HANDLE. THE THREAD OF THE PROXIMAL HANDLE COMPONENT LOOKS VISUALLY INTACT WITH NO VISIBLE DEFORMATION. TO TEST THE FUNCTIONALITY A FUNCTIONAL TEST WAS PERFORMED, REFER TO FUNCTIONAL TEST SECTION FOR RESULTS. THE DISTAL HANDLE COMPONENT SHOWS NORMAL SIGNS OF USAGE, EXCEPT OF THE THREAD WHICH CONNECTS TO THE AVENIR STEM. THE THREAD IS HIGHLY DAMAGED AND DEFORMED. THE INDIVIDUAL THREADS ARE ALMOST COMPLETELY SHORN. AVENIR EXTRACTOR WITH SLIDING HAMMER REF: 01.06808.300, LOT: 4023559: THE EXTRACTOR INSTRUMENT WAS AGAIN RECEIVED IN DISASSEMBLED STATE (THREE SEPARATE PIECES). ALSO FOR THE SECOND INSTRUMENT, NO CONSPICUOUSNESS COULD BE IDENTIFIED ON THE SLIDING HAMMER AND ON THE PROXIMAL COMPONENT OF THE HANDLE. THE THREAD OF THE PROXIMAL HANDLE COMPONENT LOOKS VISUALLY INTACT WITH NO VISIBLE DEFORMATION. A FUNCTIONAL TEST WAS PERFORMED, REFER TO FUNCTIONAL TEST SECTION FOR RESULTS. THE DISTAL HANDLE COMPONENT SHOWS NORMAL SIGNS OF USAGE, EXCEPT OF THE THREAD WHICH CONNECTS TO THE AVENIR STEM. THE THREAD IS HIGHLY DAMAGED AND DEFORMED. THE INDIVIDUAL THREADS ARE ALMOST COMPLETELY SHORN. BOTH INSTRUMENT SHOW THE SAME FAILURE MODE. BASED ON THIS VISUAL EXAMINATION THE REPORTED EVENTS CAN BE CONFIRMED. - FUNCTIONAL TEST: A FUNCTIONAL TEST WAS PERFORMED TO CHECK THE ASSEMBLY CONDITION OF THE TWO INSTRUMENTS. FOR BOTH INSTRUMENTS THE THREE DEVICE COMPONENTS COULD BE ASSEMBLED AND DISASSEMBLED AS INTENDED WITHOUT ANY DIFFICULTIES. THEREFORE, THE THREAD OF THE PROXIMAL HANDLE COMPONENT IS STILL INTACT IN BOTH CASES. REVIEW OF PRODUCT DOCUMENTATION: - COMPATIBILITY: COMPATIBILITY CHECK COULD NOT BE PERFORMED AS ONLY ONE PRODUCT HAD BEEN REPORTED. INSPECTION PLAN: - BATCH 4023559 FINAL INSPECTION ACCORDING TO DHR PAGE 16/27: - CHARACTERISTIC THREAD M6 WITH SCOPE OF TESTING: 50%. MEANS OF INSPECTION: THREAD GAUGE. BATCH 4023553 FINAL INSPECTION ACCORDING TO DHR PAGE 15/27: - CHARACTERISTIC THREAD M6 WITH SCOPE OF TESTING: 50%. MEANS OF INSPECTION: THREAD GAUGE. ROOT CAUSE ANALYSIS THE ROOT CAUSE ANALYSIS CAN BE RELATED TO A CORRECTIVE AND PREVENTIVE ACTION (CAPA-03502), WHERE THE SAME DAMAGE MODE WAS ADDRESSED. ACCORDING TO CAPA CA-03502: BASED ON THE CAUSE-EFFECT/ FISHBONE ANALYSIS AND A COMPARISON OF 2 SIMILAR INSTRUMENTS (01.00109.801 AND 01.06808.300), THE MOST LIKELY ROOT CAUSE FOR THE FAILURES OF DEVICE 01.06808.300 IS DESIGN, ESPECIALLY: - THE MATERIAL 1.4435 (THREAD MANUFACTURED FROM AUSTENITIC AND NOT MARTENSITIC STAINLESS STEEL AS E.G. 1.4021.) MATERIAL 1.4435 CANNOT BE HARDENED WHILE 1.4021 CAN BE HARDENED, THUS PROVIDING AN INCREASED RESISTANCE AGAINST WEAR. - THE 2 PIECE DESIGN (ADDITIONAL INTERFACE AND WELDING) ALTHOUGH THE DESIGN MEETS THE SPECIFIED REQUIREMENT, DESIGN CHANGES ARE EXPECTED TO DECREASE THE COMPLAINT RATE FOR THE BREAKAGE/DEFORMATION OF THE THREAD. THEREFORE, A DESIGN CHANGE WAS PERFORMED TO ADDRESS THE ISSUE. THE CHANGE PROJECT HAS BEEN FULLY PERFORMED AND WAS CLOSED ON NOV 30, 2017. NEVERTHELESS, AS THE SEVERITY FOR A POTENTIAL HARM TO THE PATIENT OR USER HAS BEEN ASSESSED TO BE MINOR AND DUE TO THE LOW COMPLAINT RATE NO CORRECTION WAS PERFORMED REGARDING THE PRODUCTS ON THE MARKET, THE INSTRUMENT SUBJECT TO THIS INVESTIGATION IS STILL OF THE OLD DESIGN AS THE DEVICE WAS MANUFACTURED IN 2014 WITH THE OLD DESIGN DRAWING. ADDITIONALLY, SPECIFIC ROOT CAUSE DETERMINATION HAS BEEN PERFORMED USING THE APPLICABLE RISK FIL RMW: - INSTRUMENT BREAKS, DEFORMS, DIVERGES IMPAIRING ITS FUNCTION DUE TO INADEQUATE DESIGN FOR INTENDED PERFORMANCE => POSSIBLE, AS THE DAMAGED INSTRUMENT IS THE OLD DESIGN BEFORE DESIGN CHANGE, THIS CAUSE CANNOT BE EXCLUDED. HOWEVER, AS STATED WITHIN CAPA CA-03502, INSTRUMENTS OF THE OLD DESIGN CAN STILL BE USED. - INSTRUMENT BREAKS, DEFORMS, DIVERGES IMPAIRING ITS FUNCTION. DUE TO MECHANICAL PROPERTIES OF MATERIAL INSUFFICIENT => POSSIBLE, AS THE DAMAGED INSTRUMENT IS OF THE OLD DESIGN WITH PREVIOUS MATERIAL APPLICABLE BEFORE DESIGN CHANGE, THIS CAUSE CANNOT BE EXCLUDED. HOWEVER, AS STATED WITHIN CAPA CA-03502 INSTRUMENTS OF THE OLD DESIGN CAN STILL BE USED. - DAMAGED INSTRUMENTS, IMPLANTS, BODY OR WRONG OPERATIONAL STEP DUE TO SURGEON OR STAFF UNFAMILIAR WITH INSTRUMENT USAGE AND HANDLING => POSSIBLE, AS EXCEPTIONALLY HIGH FORCE OR APPLICATION OF FORCES AT AN ANGLE COULD DAMAGE THE THREAD DUE TO WRONG USAGE AND HANDLING. - INSTRUMENT CANNOT BE USED WITH THE MATING INSTRUMENT OR MATING IMPLANT AS INTENDED DUE TO SURGEON OR STAFF UNFAMILIAR WITH INSTRUMENT USAGE AND HANDLING => POSSIBLE, AS THE THREAD WAS DAMAGED. THIS CAN BE A CONSEQUENCE OF INAPPROPRIATE USAGE AND HANDLING. - DAMAGED INSTRUMENTS, IMPLANTS, BODY OR WRONG OPERATIONAL STEP DUE TO SURGEON OR STAFF UNFAMILIAR WITH INSTRUMENT USAGE AND HANDLING => POSSIBLE, AS EXCEPTIONALLY HIGH FORCE OR APPLICATION OF FORCES AT AN ANGLE COULD DAMAGE THE THREAD DUE TO WRONG USAGE AND HANDLING. - INSTRUMENT BREAKS OR DEFORMS DUE TO OFF-LABEL / ABNORMAL-USE => POSSIBLE, AS ABNORMAL USE COULD RESULT IN EXCEPTIONALLY HIGH FORCE OR WRONG FORCE DISTRIBUTION WHICH DAMAGES THE THREAD. - FRACTURE OF INSTRUMENT DUE TO GENERAL CORROSION (CREVICE, PITTING, GALVANIC) => NOT POSSIBLE AS NO INDICATION OF CORROSION WAS FOUND ON THE DAMAGED SITE. CONCLUSION SUMMARY: THE DAMAGED INSTRUMENTS HAVE BEEN RETURNED FOR AN INVESTIGATION. BASED ON THE VISUAL EXAMINATION THE COMPLAINT, CONSISTING OF A DAMAGED THREAD ON TWO DEVICES, COULD BE CONFIRMED. THE VISUAL EXAMINATION SHOWED THAT ON BOTH DEVICES THE THREAD CONNECTING TO THE AVENIR STEM IS HIGHLY DEFORMED. ALL OTHER PARTS SHOW NORMAL SIGNS OF USAGE. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. AS SIMILAR EVENTS HAVE BEEN REPORTED, A CORRECTIVE AND PREVENTIVE ACTION HAD ALREADY BEEN INITIATED AND COMPLETED INCLUDING THE DESIGN CHANGE (CLOSURE DATE NOV 30, 2017) AS OUTCOME. NEVERTHELESS, AS THE SEVERITY FOR A POTENTIAL HARM TO THE PATIENT OR USER HAS BEEN ASSESSED TO BE MINOR AND DUE TO THE LOW COMPLAINT RATE NO CORRECTION WAS PERFORMED REGARDING THE PRODUCTS ON THE MARKET, THE INSTRUMENTS SUBJECT TO THIS INVESTIGATION ARE STILL OF THE OLD DESIGN. ACCORDING TO CA-03502 OUTCOME, THERE ARE SEVERAL CONDITIONS THAT MIGHT HAVE CONTRIBUTED TO THIS FAILURE, E.G.: CONTAMINATED THREAD BY FOREIGN PARTICLES OR SUBSTANCES THAT CHANGE THE FORCE DISTRIBUTION; EXCEPTIONALLY HIGH LOADS OR LOADS IN NON-AXIAL DIRECTION THAT MAY CHANGE THE LOAD DISTRIBUTION ON THE THREAD; OR THE THREAD IS NOT FULLY TIGHTENED SO THAT NOT ALL THREAD TURNS ARE LOADED. THE NEED FOR FURTHER 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

    CONCOMITANT MEDICAL PRODUCTS: EXTR. WITH SL. HAMMER, ITEM# 01.06808.300, LOT# 4023559. THE MANUFACTURER DID NOT RECEIVE THE DEVICE YET, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. 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). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT 0009613350-2018-01187.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON TRIED TO EXTRACT A STEM AND DOING SO DAMAGED THE THREAD OF TWO INSTRUMENTS AT THE DISTAL PART. ALL PIECES WERE RETRIEVED. NO DELAY OF SURGERY AND NO HARM TO PATIENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981710 EXTRACTOR WITH SLIDING HAMMER N/A HWA ZIMMER GMBH N/A 4023553 00889024288669

    Patients

    Seq Age Sex Outcome Treatment
    1