BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR WITH SLIDING HAMMER

    MDR report key: 6928119 · Received October 9, 2017

    Report

    Report Number
    0009613350-2017-01403
    Event Type
    Malfunction
    Date Received
    October 9, 2017
    Date of Event
    September 11, 2017
    Report Date
    November 14, 2017
    Manufacturer
    ZIMMER GMBH
    Product Code
    HWB
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. 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).

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS WERE MADE AVAILABLE. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: INSTRUMENT JAMMED. . DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REVIEW OF EVENT DESCRIPTION: AN AVENIR EXTRACTION INSTRUMENT WITH HAMMER (REF: 01.06808.300 LOT: 4023935) HAS BEEN RECEIVED. IT HAS BEEN REPORTED THAT THE INSTRUMENT WAS STUCK TOGETHER. THE SURGEON STATES THAT HE WAS UNABLE TO UNSCREW THE INSTRUMENT. FURTHER HE STATES THAT NO DELAY IN SURGERY AND NO HARM TO THE PATIENT OCCURED. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS WERE RECEIVED. DEVICES ANALYSIS: VISUAL EXAMINATION: THE EXTRACTION INSTRUMENT WAS RECEIVED SCREWED TOGETHER. THE HOLE FOR FLUSHING OF THE FEMALE CONNECTION THREAD SHOWS DEFORMATION, BASED ON THE DEFORMATION IT CAN BE ASSUMED THAT THE SURGEON WAS TRYING TO UNSCREW THE INSTRUMENT BY PUTING A DEVICE IN THIS HOLE. AS THE DAMAGE IS ON THE LEFT SIDE OF THE HOLE AREA, THIS INDICATES THAT WHEN APPLYING FORCE THE THREAD WAS TIGHTED TOGETHER AND NOT LOOSENED. THE FLANKS OF THE MALE THREAD SHOWS SOME CHATTER MARKS. FURTHER SOME SMALL SIGNS OF CORROSION ON THE WASHING SYMBOL AND ON THE CONNECTION AREA ARE VISIBLE. - MEASUREMENTS: TO ENSURE THE CONNECTION OF THE TWO PARTS HAVE CLEARANCE, RELEVANT DIMENSIONS WERE MEASURED WITH THE CALIPER. INNER DIAMETER 9H7 ACCORDING DRAWING : SPECIFICATION: MAX. 9.015MM; MIN. 9.00MM -MEASURED VALUE: 9.01MM OUTER DIAMETER 9G8 ACCORDING DRAWING: -SPECIFICATION: MAX. 8.995MM; MIN. 8.973.MM -MEASURED VALUE: 8.98 MM CONCLUSION: THE CONNECTION HAS ENOUGH CLEARANCE AND IS NOT TOO THIGHT FOR IT'S FUNCTION - FUNCTIONAL TEST: IN A FIRST TEST IT WAS TRIED TO UNSCREW THE INSTRUMENT BY HAND, BUT IT WAS NOT POSSIBLE TO UNSCREW THE INSTRUMENT. THEREFORE A FUNCTIONAL TEST WAS PERFORMED USING A VICE WITH SOFT JAWS AND A PIPE WRENCH. THE HANDLE WAS FIXATED IN THE VICE, WITH THE PIPE WRENCH IT WAS TRIED TO UNSCREW THE DISTAL PART OF THE INSTRUMENT. WITH THIS SET-UP IT WAS POSSIBLE TO UNSCREW THE INSTRUMENT. AS IT WAS NOT POSSIBLE TO UNSCREW THE INSTRUMENT WITHOUT THE HELP OF ADDITIONAL TOOLS, THE REPORTED EVENT CAN BE CONFIRMED. HOWEVER AFTER UNSCREWING THE TWO PARTS A WATER SOLUBLE LUBRICANT WAS APPLIED AT THE THREAD AREA AND AS A RESULT THE TWO PARTS CAN BE SCREWED TOGETHER AND UNSCREWED WITHOUT ANY DIFFICULTIES. REVIEW OF PRODUCT DOCUMENTATION: IFU STATES ON PAGE 6: "AFTER CLEANING, LUBRICATE METAL, MOVING PARTS WITH A WATER SOLUBLE LUBRICANT APPROVED FOR USE WITH MEDICAL DEVICES. REASSEMBLE AND TIGHTEN SCREWS WHERE APPROPRIATE." 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. - INSTRUMENT BREAKS, DEFORMS, DIVERGES IMPAIRING ITS FUNCTION DUE TO MECHANICAL PROPERTIES OF MATERIAL INSUFFICIENT => NOT POSSIBLE -> ACCORDING TO MATERIAL COMPATIBILITY SPECIFICATION THE MATERIAL HAS BEEN TESTED. FURTHER, A SYSTEMATIC ISSUE WITH MATERIAL PROPERTIES 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 VISUAL INSPECTION INDICATES THE SURGEON MIGHT HAVE TIGHTENED THE THREAD CONNECTION WITH HELP OF THE LITTLE HOLE INSTEAD OF LOOSENING IT. FURTHER IT APPEARS NO LUBRICANT, AS DESCRIBED IN THE IFU, WAS USED. - INADEQUATE USABILITY OF INSTRUMENT DUE TO INADEQUATE DESIGN FOR INTENDED HANDLING PERFORMANCE => NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - INSTRUMENT BREAKS OR DEFORMS DUE TO OFF-LABEL / ABNORMAL-USE => POSSIBLE, AS THE VISUAL INSPECTION INDICATES THE SURGEON MIGHT HAVE TIGHTENED THE THREAD CONNECTION WITH HELP OF THE LITTLE HOLE INSTEAD OF LOOSENING IT. THIS CAN BE DESCRIBED AS ABNORMAL-USE. - INSTRUMENT CANNOT BE USED WITH THE CONNECTED INSTRUMENT AS INTENDED DUE TO FAILURE OF INSTRUMENT ASSEMBLY CONDITION => POSSIBLE, AS THE TWO INSTRUMENT PARTS COULD NOT BE DISASSEMBLED BY HAND AS INTENDED. CONCLUSION SUMMARY: BASED ON THE RETURNED PRODUCT AND THE GIVEN INFORMATION THE COMPLAINT COULD BE CONFIRMED. THE VISUAL EXAMINATION AND THE FUNCTIONAL TEST DID CONFIRM THAT WITHOUT THE HELP OF TOOLS IT WAS NOT POSSIBLE TO UNSCREW THE INSTRUMENT. A POSSIBLE ROOT CAUSE COULD BE THAT THE TWO PARTS OF THE EXTRACTION HAMMER GOT STUCK TOGETHER DUE TO WEAR AND THE CHATTER MARKS ON THE FLANKS OF THE THREAD. ALSO IT APPEARS THE INSTRUMENT'S THREAD AREAS WHERE NOT MAINTAINED WITH A LUBRICANT. THIS IS UNDERLINED BY THE FUNCTIONAL TEST CONDUCTED AS PART OF THIS INVESTIGATION: WHEN APPLYING LUBRICANT AFTER THE LOOSENING OF THE CONNECTION, THE TWO PARTS COULD BE SCREWED TOGETHER AND UNSCREWED WITHOUT ANY DIFFICULTIES. FURTHER THE VISUAL INSPECTION INDICATES THAT THE SURGEON/ OR STAFF MIGHT HAVE FALSELY TIGHTENED THE CONNECTION OF THE INSTRUMENT WITH HELP OF THE LITTLE HOLE FOR FLUSHING, INSTEAD OF LOOSENING IT (TURNING IN THE WRONG DIRECTION). FOR THE CORROSION VISIBLE IN THE CONNECTION AREA, A POSSIBLE ROOT CAUSE COULD BE THAT THE INSTRUMENT MIGHT HAVE BEEN CLEANED/ STERILIZED IN AN ASSEMBLED STATE. AS A RESULT HUMIDITY REMAINED IN THE CONNECTION/ THREAD AREA AND ACTED AS A STARTING POINT FOR THE CORROSION. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. CONCLUDING, BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGERY ON AN UNKNOWN DATE IT WAS NOT POSSIBLE TO UNSCREW THE NODULAR SLAPHAMMER, THE DISTAL PART WAS "STUCK". IT WAS ALSO REPORTED THAT THERE WAS NO DELAY IN THE CASE, AND NO HARM TO PATIENT. 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
    707932 EXTRACTOR WITH SLIDING HAMMER UNKNOWN HWB ZIMMER GMBH N/A 4023935

    Patients

    Seq Age Sex Outcome Treatment
    1