BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVITAN, RASP, DISTAL, CURVED, 14/140

    MDR report key: 7420827 · Received April 11, 2018

    Report

    Report Number
    0009613350-2018-00439
    Event Type
    Injury
    Date Received
    April 11, 2018
    Date of Event
    March 19, 2018
    Report Date
    August 8, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW: THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: A TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: BROKEN RASP. FURTHER INVESTIGATION HAS BEEN PERFORMED AND A FIELD SAFETY CORRECTIVE ACTION HAS BEEN INITIATED (SEE BELOW). ONE ADDITIONAL SIMILAR INVESTIGATED EVENT FOR THE LOT NUMBER 05.183284 HAS BEEN FOUND. NO ADDITIONAL SIMILAR INVESTIGATED EVENT WITHIN 6 MONTHS FOR ITEM NUMBER 01.00409.612 HAS BEEN FOUND. REVIEW OF EVENT DESCRIPTION: DURING A SURGERY ON MARCH 19, 2018 WHILE RASPING THE FEMUR, THE RASP GOT STUCK IN FEMUR. IN AN ATTEMPT TO REMOVE IT, THE CONNECTION TO THE HANDLE FRACTURED AND THE STUCK RASP COULD ONLY BE REMOVED BY SPLITTING THE FEMUR. SURGERY WAS DELAYED BY 120 MIN. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS WERE RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. ACCORDING TO THE AVAILABLE INFORMATION, THE PRODUCT LOCATION IS UNKNOWN. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION 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 => POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. THE SUPPLIER GEHRING CUT IS USING A HIGHER QUALITY VERSION OF THE MATERIAL THAN REQUIRED. BUT THERE IS NO INFORMATION ABOUT THE RAW MATERIAL THAT WAS USED BY THE SUPPLIER EUROCUT. - INSTRUMENT CANNOT BE USED WITH THE MATING INSTRUMENT OR MATING IMPLANT AS INTENDED DUE TO FAILURE OF INSTRUMENT MATING CONDITION => 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. => POSSIBLE, AS THE INSTRUMENT WAS MANUFACTURED IN 2005 AND MIGHT HAVE BEEN ON THE MARKET FOR MORE THAN 13 YEARS AND - INSTRUMENT BREAKS OR DEFORMS DUE TO OFF-LABEL / ABNORMAL-USE => POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. CONCLUSION SUMMARY: THE INSTRUMENT HAS NOT BEEN RETURNED FOR AN INVESTIGATION, THEREFORE THE EVENT COULD NOT BE CONFIRMED. IT MIGHT BE POSSIBLE THAT THE PIN OF THE RASP HAS BROKEN OFF. THE RASP WAS MANUFACTURED IN 2005 AND MIGHT HAVE BEEN ON THE MARKET FOR MORE THAN 13 YEARS. THEREFORE IT MIGHT HAVE BEEN USED EXCESSIVELY. THIS DEVICE WITH REF 01.00409.612 LOT 05.183284 WAS MANUFACTURED BY EUROCUT. IN 2003, GEHRINGCUT AG STARTED MANUFACTURING THEM AS WELL AND SINCE 2006 IT IS THE ONLY SUPPLIER OF THIS INSTRUMENT. SEVERAL COMPLAINTS CONCERNING BROKEN CONNECTION PINS OF RASPS MANUFACTURED BY EUROCUT WERE REPORTED TO ZIMMER GMBH. WITHIN FURTHER INVESTIGATION (CAPA CA-03895) IT WAS DETERMINED THAT A SPECIFIC ROOT CAUSE FOR THE SIGNIFICANT HIGHER INCIDENT RATE FOR THE RASPS PRODUCED BY SUPPLIER EUROCUT COULD NOT BE FOUND. HOWEVER, BASED ON THE ROOT CAUSE ANALYSIS, THE MOST LIKELY ROOT CAUSE FOR THE HIGHER NUMBER OF BROKEN RASPS PRODUCED BY EUROCUT, IS LINKED TO THE USE OF A RAW MATERIAL OF LOWER QUALITY. FURTHER POSSIBLE INFLUENCING FACTORS ARE DIFFERENT MANUFACTURING STEPS APPLIED BY THE SUPPLIERS AND THE AGE OF THE RASPS. IN 2017, IT WAS DECIDED TO REPLACE ALL RASPS FROM THE SUPPLIER EUROCUT WITH NEW ONES FROM THE SUPPLIER GEHRING CUT. ZIMMER GMBH INITIATED A FIELD SAFETY CORRECTIVE ACTION (REMOVAL) OF CERTAIN REVITAN RASP INSTRUMENTS: FIELD ACTION REF: FA 2017-05 (ZFA 2017-404). THIS FIELD ACTION FA 2017-05 (ZFA2017-404) IS EXPECTED TO BE CLOSED BY THE END OF 2018. IT WAS CONFIRMED THAT THE HOSPITAL HAS BEEN INFORMED ABOUT THE FIELD ACTION PRIOR TO THE EVENT DATE. ZIMMER GMBH INITIATED A FIELD SAFETY CORRECTIVE ACTION (REMOVAL) OF CERTAIN REVITAN RASP INSTRUMENTS. THE AFFECTED DEVICES WERE MANUFACTURED BY A SPECIFIC VENDOR BETWEEN 2002 AND 2008. THE ISSUE RELATES TO THE POTENTIAL BREAKAGE OF THE INSTRUMENT INTRA-OPERATIVELY AFTER EXTENSIVE USE OVER TIME. THERE IS A POTENTIAL RISK FOR BREAKAGE OF THE RASPS DURING THE SURGERY. THE CAUSE OF THE BREAKAGE IS MULTIFACTORIAL. TRENDING OF COMPLAINT DATA SHOWED THAT THE FRACTURE RATE FOR THESE LOTS WERE FOUND TO BE HIGHER (0.54%) THAN THE FRACTURE RATE IF THE REVITAN RASP INSTRUMENTS MANUFACTURED BY A DIFFERENT VENDOR (0.038%). ZIMMER GMBH HAS THEREFORE DETERMINED TO CONDUCT A FIELD SAFETY CORRECTIVE ACTION BY REMOVING THE AFFECTED INSTRUMENTS FROM THE MARKET. THE ACTION INVOLVES INFORMING ALL AFFECTED CUSTOMERS OF THE ISSUE AND ARRANGING THE REMOVAL OF THE AFFECTED DEVICES FROM THE MARKET. ZIMMER BIOMET EMPHASISES THE IMPORTANCE TO USERS TO ADHERE TO THE APPLICABLE SURGICAL TECHNIQUE, INSTRUCTION FOR USE (IFU) AND ORTHOPAEDIC REUSABLE DEVICE INSTRUCTIONS. ALL THE AFFECTED HOSPITALS AND SURGEONS THAT RECEIVED THE PRODUCTS WERE NOTIFIED AND ARE INSTRUCTED TO FOLLOW THE INSTRUCTIONS REPORTED IN THE FSN. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET WINTERTHUR AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET WINTERTHUR MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K110836. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(6) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(6) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K110836. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. A LOT NUMBER WAS RECEIVED FOR THE DEVICE, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. 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 DURING A SURGERY WHILE RASPING THE FEMUR THE RASP GOT STUCK IN THE FEMUR. THE STUCK RASP COULD ONLY BE REMOVED BY SPLITTING THE FEMUR. SURGERY WAS DELAYED BY 120 MIN BECAUSE OF DIFFICULTY IN REMOVAL OF THE RASP AND CONVERSION OF THE SURGICAL TECHNIQUE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263713 REVITAN, RASP, DISTAL, CURVED, 14/140 JDI ZIMMER GMBH N/A 05.183284

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R