BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE WIRE WITH THREADED TIP, 2.5 MM, 230 MM

    MDR report key: 6405494 · Received March 15, 2017

    Report

    Report Number
    0009613350-2017-00375
    Event Type
    Malfunction
    Date Received
    March 15, 2017
    Date of Event
    March 4, 2016
    Report Date
    March 15, 2017
    Manufacturer
    ZIMMER GMBH
    Product Code
    FZX
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO LOT NUMBERS WERE PROVIDED FOR THE GUIDE WIRE WITH THREADED TIP, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. AN E-MAIL REQUESTING MISSING DEVICE DATA INFORMATION WAS SENT TO THE COMPLAINANT. AT ZIMMER GMBH 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 GMBH 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. EVENT SUMMARY: IT WAS REPORTED THAT DURING SURGERY THE DHS REAMER SEEMED TO JAM THEN PUSHED FORWARD BREAKING THE 2.5X230MM GUIDE PIN LEAVING PROXIMAL END OF THE GUIDE PIN IN THE FEMORAL HEAD. THE SURGEON MANAGED TO GET THE GUIDE PIN OUT OF THE FEMORAL HEAD AND COMPLETE THE SURGERY SUCCESSFULLY. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS: VISUAL EXAMINATION: THE TIP OF THE FRACTURED GUIDE PIN WAS RETURNED FOR AN INVESTIGATION. THIS PART OF THE PIN IS NOT MARKED WITH THE REF OR LOT. THEREFORE, THE LOT REMAINS UNKNOWN. SEVERAL SIGNS OF USAGE ARE VISIBLE ON THE FRACTURED INSTRUMENT. ESPECIALLY THERE ARE HEAVY SCRATCHES CLOSE TO THE BREAKING POINT OF THE WIRE. MOREOVER, THE THREE COMPONENTS OF THE TRIPLE REAMER WERE RETURNED FOR AN INVESTIGATION. THEY CAN BE ASSEMBLED WITHOUT DIFFICULTIES. ONLY SMALL SIGNS OF USAGE ARE VISIBLE ON THE REAMER (REF 110.25.180). HOWEVER, THE DRILL (REF 110.25.075) HAS DEFORMED BLADES AT THE TIP. MEASUREMENTS: THE MAIN OUTER DIAMETERS OF THE INSTRUMENTS WERE MEASURED USING A MICROMETER. THE OUTER DIAMETER OF THE GUIDE WIRE WAS MEASURED TO BE Ø2.495 MM(SPECIFICATION: Ø2.5 H9 MM). THE OUTER DIAMETER OF THE DRILL BIT WIRE WAS MEASURED TO BE Ø 7.98MM (SPECIFICATION: Ø8 0/-0.05 MM). THESE VALUES ARE WITHIN SPECIFICATION. ALSO THE OUTER DIMENSION OF THE BLADE EDGES OF THE REAMER (REF 110.25.180) ARE WITH A MEASURED VALUE Ø 12.775MM WITHIN THE SPECIFICATIONS OF Ø12.8 0/-0.04 MM. EXAMINATION OF FRACTURE SURFACE: THE FRACTURE SURFACE OF THE GUIDE WIRE WAS EXAMINED CLOSER USING A MICROSCOPE. THE FORM FITS THE SURFACE OF THE DRILL BLADES. REVIEW OF PRODUCT DOCUMENTATION: INSPECTION PLAN FOR REF 110.25.180: CHARACTERISTIC FEATURE "OUTER DIAMETER Ø12.8 0/-0.04" WITH SCOPE OF TESTING: 100%. MEANS OF INSPECTION: MICROMETER. CHARACTERISTIC FEATURE "BORE HOLE Ø8 +0.15/+0.05" WITH SCOPE OF TESTING: 100% MEANS OF INSPECTION: TEST PIN. INSPECTION PLAN FOR REF 110.25.075: CHARACTERISTIC FEATURE "OUTER DIAMETER Ø7.52 0/-0.1" WITH SCOPE OF TESTING: 100%. MEANS OF INSPECTION: MICROMETER. THE SURGICAL TECHNIQUE FOR THE DYNAMIC HIP SCREW PLATE SYSTEM WAS REVIEWED. IT IS EXPLAINED THAT THE CORRECT POSITIONING OF THE GUIDE WIRE SHOULD BE CHECKED USING THE IMAGE INTENSIFIER WITH BOTH ANTERIOR-POSTERIOR AND AXIAL VIEWS. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION FOR THE GUIDE WIRE AND THE TRIPLE REAMER USING RMW: ONLY GUIDE WIRE: INSTRUMENT, BREAKS, DEFORMS, DIVERGE, OR PARTS REMAIN IN WOUND DUE TO INADEQUATE DESIGN FOR INTENDED PERFORMANCE. NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF A TREND REVIEW. ONLY REAMER: INSTRUMENT, BREAKS, DEFORMS, DIVERGE, OR PARTS REMAIN IN WOUND DUE TO INADEQUATE DESIGN FOR INTENDED PERFORMANCE NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF A TREND REVIEW. INSTRUMENT, BREAKS, DEFORMS, DIVERGE, OR PARTS REMAIN IN WOUND. DUE TO MECHANICAL PROPERTIES OF MATERIAL INSUFFICIENT NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF A TREND REVIEW. FRACTURE OF INSTRUMENT DUE TO GENERAL CORROSION (CREVICE, PITTING, GALVANIC) NOT POSSIBLE -> VISUAL EXAMINATION DID NOT SHOW ANY SIGNS OF CORROSION. INSTRUMENT, BREAKS, DEFORMS, DIVERGE, OR PARTS REMAIN IN WOUND DUE TO INADEQUATE DESIGN FOR INTENDED PERFORMANCE. NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF A TREND REVIEW. DAMAGED INSTRUMENTS, IMPLANTS, BODY OR WRONG OPERATIONAL STEP DUE TO SURGEON OR OR STAFF UNFAMILIAR WITH INSTRUMENT USAGE AND HANDLING => POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. DAMAGED INSTRUMENTS, IMPLANTS, BODY OR WRONG OPERATIONAL STEP DUE TO SURGEON OR OR STAFF UNFAMILIAR WITH INSTRUMENT USAGE AND HANDLING => POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. INSTRUMENT BREAKS OR DEFORMS DUE TO OFF-LABEL / ABNORMAL-USE => POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. CONCLUSION SUMMARY: THE PROXIMAL PART OF THE FRACTURED GUIDE WIRE AS WELL AS THE TRIPLE REAMER WERE RETURNED FOR AN INVESTIGATION. THE TRIPLE REAMER CAN BE ASSEMBLED WITHOUT DIFFICULTIES AND THE MEASURED DIMENSIONS ARE WITHIN SPECIFICATIONS. HOWEVER, THE BLADES OF THE DRILL HAS DEFORMATIONS AND THE FRACTURE SURFACE OF THE GUIDE WIRE FITS THE BLADES OF THE DRILL. THEREFORE IT CAN BE ASSUMED THAT THE GUIDE WIRE WAS BROKEN OFF BY THE DRILL DURING DRILLING. THIS IS ALSO SUPPORTED BY THE HEAVY SCRATCHES OF THE GUIDE WIRE CLOSE TO THE BREAKAGE POINT. POSSIBLE REASONS THEREFORE COULD BE THAT THE GUIDE WIRE WAS BENT AFTER INSERTION OR THAT THE TRIPLE REAMER WAS NOT APPLIED IN LINE WITH THE GUIDE WIRE. TO AVOID THIS, THE SURGICAL TECHNIQUE POINTS OUT THE IMPORTANCE OF ENSURING THE CORRECT POSITIONING OF THE GUIDE PRIOR TO DRILLING. HOWEVER, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES OR OTHER SOURCE DOCUMENTS FOR REVIEW. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. (B)(4). THE ACTUAL DEVICE REPORTED IN SECTION D IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (I.E GUIDE WIRE Ø 2.0X440) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY ON (B)(6) 2016, A GUIDE WIRE WITH THREADED TIP BROKE IN THE FEMORAL HEAD. ALL PARTS COULD BE REMOVED FROM THE PATIENT AND THE SURGERY WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189195 GUIDE WIRE WITH THREADED TIP, 2.5 MM, 230 MM UNKNOWN FZX ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other