BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL 3.2X56.5

    MDR report key: 7612790 · Received June 19, 2018

    Report

    Report Number
    0009613350-2018-00638
    Event Type
    Malfunction
    Date Received
    June 19, 2018
    Date of Event
    May 24, 2018
    Report Date
    November 14, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    HTW
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. ADDITIONAL: IF FOLLOW-UP, WHAT TYPE. CORRECTION: DATE OF EVENT, DATE OF REPORT, DATE REC¿D BY MFR, PMA/510K. DEVICE HISTORY RECORDS (DHR): THE DHR CHECK COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. THE MISSING INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE. 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. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: DRILL BIT BROKEN. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT DURING A SURGERY TWO DRILL BITS BROKEN. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. ACCORDING TO THE INFORMATION RECEIVED, THE DEVICES WERE DISCARDED AT THE HOSPITAL AS BIOHAZARD. 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 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 MECHANICAL PROPERTIES OF MATERIAL WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. FRACTURE OF INSTRUMENT DUE TO GENERAL CORROSION (CREVICE, PITTING, GALVANIC) POSSIBLE, THE DEVICES ARE NOT AT HAND FOR INVESTIGATION. NO PICTURE OF THE DEVICES WAS RECEIVED. IT IS UNKNOWN IF THE DEVICES HAVE CORRODED. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. DAMAGED INSTRUMENTS, IMPLANTS, BODY OR WRONG OPERATIONAL STEP DUE TO SURGEON OR STAFF UNFAMILIAR WITH INSTRUMENT USAGE AND HANDLING POSSIBLE, NO DETAILED INFORMATION OF THE REPORTED EVENT WAS RECEIVED, NEITHER SURGICAL REPORT WAS PROVIDED. THEREFORE IT IS UNKNOWN IF SURGICAL TECHNIQUE WAS FOLLOWED. INSTRUMENT BREAKS OR DEFORMS DUE TO OFF-LABEL / ABNORMAL-USE POSSIBLE, NO DETAILED INFORMATION OF THE REPORTED EVENT WAS RECEIVED, NEITHER SURGICAL REPORT WAS PROVIDED. THEREFORE IT IS UNKNOWN IF SURGICAL TECHNIQUE WAS FOLLOWED. CONCLUSION SUMMARY: IT WAS REPORTED THAT DURING A SURGERY TWO DRILL BITS BROKE, THIS CAUSED A SLIGHT SURGERY DELAY (EXACT TIME UNKNOWN) DUE TO REPLACEMENT OF THE DRILL BIT. THE TWO DRILL BITS AND SURGICAL REPORT WERE NOT RECEIVED FOR INVESTIGATION; EXACT EVENT DETAILS ABOUT CIRCUMSTANCE OF BREAKAGE OF THE BITS ARE UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED AND IS CURRENTLY NOT AVAILABLE. THE PRE-CONDITION OF THE COMPONENTS IS UNKNOWN, IT IS UNKNOWN HOW MANY TIME THE DEVICES WERE USED PRIOR TO THE BREAKAGE AND IF THE SURGICAL TECHNIQUE WAS FOLLOWED. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED EVENT. THEREFORE, AN EXACT ROOT CAUSE CANNOT BE DETERMINED. THE NEED FOR 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

    THE FOLLOWING REPORT IS ASSOCIATED WITH THIS EVENT: 0009613350-2018-00639. THE MANUFACTURER DID NOT RECEIVE DEVICES FOR REVIEW. IT WAS MENTIONED THAT THE INSTRUMENTS WERE DISCARDED BY THE HOSPITAL. X-RAYS OR OTHER SOURCE DOCUMENTS WERE NOT PROVIDED FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE ACTUAL DEVICE REPORTED IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (I.E BOHRER 4,5MM X 35,5MM, REF# (B)(4)) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL BIT WAS BROKEN DURING SURGERY. NO SURGERY DELAY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455509 DRILL 3.2X56.5 DRILL HTW ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 DRILL 3.2X35.5, REF# 5902, LOT# UNKNOWN