BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEASURING SETT.-INSTR. W/SCALE

    MDR report key: 6816409 · Received August 24, 2017

    Report

    Report Number
    0009613350-2017-01105
    Event Type
    Malfunction
    Date Received
    August 24, 2017
    Report Date
    January 9, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LXH
    PMA / PMN Number
    PNA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 WAS IDENTIFIED: INSTRUMENT FRACTURE AND/OR LOOSE. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT GOT LOOSE AND STUCK WITH THE SIZER IN FEMUR. THE MEASURING CONES HAVE BEEN RETURNED TOGETHER WITH THE MEASURING INSTRUMENT. IT WAS ALSO REPORTED THAT MOST LIKELY NOTHING IS WRONG WITH THE MEASURING CONES. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS WERE RECEIVED. DEVICES ANALYSIS: THE MEASURING INSTRUMENT HAS BEEN RETURNED FOR INVESTIGATION TOGETHER WITH 8 MEASURING CONES. THE MEASURING INSTRUMENT SHOWS SIGNS OF USE. ADDITIONALLY, SOME NICKS LOCATED ON ONE SIDE CLOSE TO THE JUNCTION BETWEEN MEASURING ROD AND HANDLE ARE VISIBLE AS WELL AS SOME MARKS ON THE HANDLE PLATE. THE NICKS AND MARKS ARE COMPATIBLE WITH HAMMER BLOWS. ADDITIONALLY, THE TIP OF THE INSTRUMENT IS FRACTURED AND THE MISSING FRAGMENT REMAINED IN THE MEASURING CONE OF SIZE 3. THE FRACTURE SURFACE SUGGESTS AN OVERLOAD FRACTURE. THE MEASURING CONE SIZE 3 IS SCRATCHED AND DAMAGED ON THE OUTSIDE, PROBABLY DUE TO THE USE OF INSTRUMENTS FOR REMOVAL. THE APPEARANCE OF THE OTHER MEASURING CONES DOES NOT SHOW ANY CONSPICUOUSNESS. REVIEW OF PRODUCT DOCUMENTATION: ORIGINAL M. E. MÜLLER® STRAIGHT STEM ¿ SURGICAL TECHNIQUE DESCRIBES THE USE OF THE MEASURING INSTRUMENT ON PAGE 8-9: "ON THE STRAIGHT STEM PROSTHESIS THAT IS TO BE IMPLANTED, WITH THE INTRODUCING ROD FOR MEDULLARY PLUG, A MEASURE IS NOW TAKEN FOR THE POSITION OF THE MEDULLARY PLUG, MEASURED FROM THE PROSTHETIC MEDIAL RIM INDICATING THE LEVEL OF RESECTION. THE PLUG SHOULD BE PLACED 0.5¿1 CM DISTALLY OF THE PROSTHESIS TIP." AND "AFTER THE TRIAL RASP HAS BEEN EXTRACTED, THE SIZE OF THE MEDULLARY PLUG IS DETERMINED WITH THE AID OF THE MEASURE CONE.". THE INSTRUMENT HAS A MEASURING FUNCTION. IN THE INSTRUCTIONS FOR USE (IFU) FOR SURGICAL INSTRUMENTS T IS STATED "DO NOT SUBJECT INSTRUMENTS TO HIGH LOADS AND/OR IMPACT AS BREAKAGE CAN OCCUR." 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 AND/OR MATERIAL PROPERTIES 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 -> A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - FRACTURE OF INSTRUMENT DUE TO GENERAL CORROSION (CREVICE, PITTING, GALVANIC). => NOT POSSIBLE -> DEVICE ANALYSIS DID NOT HIGHLIGHT CORROSION CLOSE TO THE FRACTURE. - INSTRUMENT BREAKS OR DEFORMS DUE TO OFF-LABEL / ABNORMAL-USE. => POSSIBLE, THE DEVICE SHOWED SOME SIGNS COMPATIBLE WITH HAMMER BLOWS. CONCLUSION SUMMARY: IT IS REPORTED THAT THE TIP OF THE INSTRUMENT GOT LOOSE AND STUCK WITH THE SIZER IN FEMUR. THE VISUAL EXAMINATION SHOWED THE FRACTURE OF THE MEASURING INSTRUMENT TIP, POSSIBLY DUE TO OVERLOAD, AND SOME SIGNS COMPATIBLE WITH HAMMER BLOWS. THE NICKS LOCATED CLOSE TO THE JUNCTION BETWEEN MEASURING ROD AND HANDLE SUGGEST THE APPLICATION OF FORCE ON THE INSTRUMENT. THE APPLICATION OF FORCE AT THIS LOCATION CAN CAUSE A BENDING MOMENT ON THE INSTRUMENT AND POSSIBLY CAUSE ITS FRACTURE. BASED ON THE INVESTIGATION, THE MOST PROBABLE ROOT CAUSE OF THE INSTRUMENT FRACTURE IS THE APPLICATION OF HIGH LOADS AND/OR IMPACTS TO THE INSTRUMENT. 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).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION IS PENDING. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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 THE TIP OF THE INSTRUMENT GOT LOOSE AND STUCK WITH THE SIZER IN FEMUR. 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
    596527 MEASURING SETT.-INSTR. W/SCALE LXH ZIMMER GMBH N/A 16.360646

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R