BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW FOR 75.11.00-05

    MDR report key: 7330252 · Received March 12, 2018

    Report

    Report Number
    0009613350-2018-00342
    Event Type
    Malfunction
    Date Received
    March 12, 2018
    Date of Event
    September 14, 2017
    Report Date
    March 12, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    HTW
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT(S): TRI-SHANK FLEX SHAFT, TEM#00-8790-007-05, LOT# UNKNOWN. AS FOR ZIMMER SPECIALISTS TO PERFORM AN IN-DEPTH ANALYSIS IT IS REQUIRED TO HAVE ALL NECESSARY INFORMATION AT HAND, IT WAS THEREFOR TRIED SEVERAL TIMES TO RECEIVE MORE INFORMATION FOR THIS CASE. ADDITIONAL INFORMATION WAS REQUESTED AT COMPLAINANT AND IS CURRENTLY NOT AVAILABLE. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. AN E-MAIL REQUESTING MISSING DEVICE DATA INFORMATION WAS SENT TO THE COMPLAINANT. AT ZIMMER (B)(4) ALL MEDICAL DEVICES PRIOR RELEASE TO MARKET UNDERGO SEVERAL QUALITY INSPECTIONS AS DEFINED IN OUR QUALITY PROCEDURES. OUR QUALITY INSPECTION- AND DEVIATION PROCEDURES ENSURE THAT ONLY PRODUCTS FULFILLING THE SPECIFICATION ARE SOLD. THESE PROCEDURES ARE PART OF THE OVERALL QUALITY MANAGEMENT SYSTEM AT ZIMMER (B)(4) AND GET REGULARLY AUDITED BY OUR NOTIFIED BODY, COMPETENT AUTHORITIES AND INTERNAL AND EXTERNAL AUDITORS. THUS, FOR ALL PRODUCTS SOLD TO THE MARKET CAN BE ASSUMED HAVING A COMPLETE AND CORRECT DHR. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: SCREW LOOSE. NO TREND ANALYSIS ON THE LOT NUMBER COULD BE PERFORMED, AS IT REMAINS UNKNOWN. EVENT SUMMARY: IT WAS REPORTED THAT A FLEXIBLE SHAFT COULD NOT BE USED DURING SURGERY BECAUSE THE SCREW WOULD NOT LOCK IT AS IT IS LOOSE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER SCREWING SYSTEM WITH A DELAY OF 15-30 MINUTES. NO MEDICAL DATA SUCH AS SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. ACCORDING TO THE INFORMATION RECEIVED, THE PRODUCT LOCATION IS UNKNOWN. REVIEW OF PRODUCT DOCUMENTATION: - INSTRUCTION FOR USE (IFU): PACKAGING INSERT IFU STATES ¿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, DIVERGE, OR PARTS REMAIN IN WOUND. DUE TO INADEQUATE DESIGN FOR INTENDED PERFORMANCE NOT POSSIBLE. A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - INSTRUMENT, BREAKS, DEFORMS, DIVERGE, OR PARTS REMAIN IN WOUND. DUE TO MECHANICAL PROPERTIES OF MATERIAL INSUFFICIENT NOT POSSIBLE. A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - INSTRUMENT CANNOT BE USED WITH THE MATING INSTRUMENT OR MATING IMPLANT AS INTENDED DUE TO FAILURE OF INSTRUMENT MATING CONDITION. POSSIBLE, AS A DETERIORATION IN FUNCTION AS A RESULT OF REPEATED USE CANNOT BE EXCLUDED. THE MANUFACTURING DATE OF THE INSTRUMENTS IS UNKNOWN. - DAMAGED INSTRUMENTS, IMPLANTS, BODY OR WRONG OPERATIONAL STEP DUE TO SURGEON OR OPERATING ROOM STAFF UNFAMILIAR WITH INSTRUMENT USAGE AND HANDLING. POSSIBLE, AS A DETERIORATION IN FUNCTION AS A RESULT OF REPEATED USE CANNOT BE EXCLUDED. THE MANUFACTURING DATE OF THE INSTRUMENTS IS UNKNOWN. ADDITIONALLY, THE SCREW IS NOT SUPPOSED TO BE UNSCREWED FROM THE FLEXIBLE SHAFT. - DAMAGED INSTRUMENTS, IMPLANTS, BODY OR WRONG OPERATIONAL STEP DUE TO SURGEON OR OPERATING ROOM STAFF UNFAMILIAR WITH INSTRUMENT USAGE AND HANDLING. POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. THE SCREW IS NOT SUPPOSED TO BE UNSCREWED FROM THE FLEXIBLE SHAFT. CONCLUSION SUMMARY: NEITHER THE PRODUCTS NOR THE LOT NUMBERS WERE AVAILABLE FOR THE INVESTIGATION. THEREFORE THE EVENT COULD NOT BE RECREATED AND IT IS UNCLEAR HOW THE SCREW COULD "UNLOCK". GENERALLY IT NEEDS TO BE CONSIDERED THAT THE LOCKING SCREW SHOULD NOT BE UNSCREWED COMPLETELY FROM THE INSTRUMENT FOR CLEANING AND DISINFECTION. THIS WOULD ONLY BE POSSIBLE BY TURNING THE SCREW CLOCKWISE. IN ORDER TO HAVE AN APPROPRIATE CLEANING AND DISINFECTION OF THE WHOLE INSTRUMENT IT IS SUFFICIENT TO LOOSEN THE SCREW (COUNTER-CLOCKWISE) BUT IT SHOULD ALWAYS REMAIN WITHIN THE FLEX SHAFT. HOWEVER, AS THE INSTRUMENTS HAVE NOT BEEN RETURNED FOR AN INVESTIGATION, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER BIOMET CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4). THE FOLLOWING REPORT IS ASSOCIATED WITH THIS EVENT: 0009613350 - 2017 - 01431.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGERY THE FLEXIBLE SHAFT TO ENGAGE THE TIP WAS UNUSABLE BECAUSE THE SCREW THAT SHOULD LOCK IT UNSCREWS AND LOSES. THE SURGERY HAS BEEN COMPLETED WITH DELAY ( 15-30 MINUTES), TIME USED TO FIND ANOTHER SCREWING SYSTEM. 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
    173263 SCREW FOR 75.11.00-05 NA HTW ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1