BEUDAMED
    FDA Adverse Event Other Summary report: N

    CM ANTIROTATION PIN SLEEVE 3.0 MM

    MDR report key: 4991520 · Received August 6, 2015

    Report

    Report Number
    9613350-2015-00951
    Event Type
    Other
    Date Received
    August 6, 2015
    Date of Event
    July 27, 2015
    Report Date
    July 27, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RECEIVED FOR EVALUATION. DEVICES ANALYSIS AFTER THE STANDARD DECONTAMINATION PROCEDURE PERFORMED AT ZIMMER BIOMET, ONLY THE NAIL AND THE TARGETING GUIDE WAS SHOWING CORROSION TRACES. THE VISUAL EXAMINATION OF THE PARTS REVEALED CORROSION ON AROUND THE SPHERES AND PLUGS IN DIVERSE PLACES ON THE INSTRUMENTS. THE RECEIVED PARTS WERE PHOTOGRAPHED AND THEN CLEANED BY A STANDARD RUST REMOVAL AGENT (15% DECONEX 34 GR). AFTER THE CLEANING WITH THE RUST REMOVAL AGENT THE CORROSION ON THE INSTRUMENT DIMINISHED. THIS WAS DOCUMENTED IN PHOTOGRAPHS. AFTERWARD, A STANDARDIZED AND POPULAR CORROSION TEST WAS PERFORMED ON THE INSTRUMENTS. THE INSTRUMENTS WERE SET FOR 45 MINUTES IN A SALTY SOLUTION. THE SALTY SOLUTION PRODUCES A CORROSIVE ATTACK TO THE SAMPLES (IN THIS CASE THE INSTRUMENT) TO EVALUATE IF THE RUST IS ORIGINATING FROM THE SAMPLE MATERIAL OR NOT. IN THIS CASE, THERE WAS NO APPEARANCE OF NEW CORROSION PRODUCTS (RUST) AFTER THE CORROSION TEST. THIS MEANS THAT THE CORROSION IS NOT ORIGINATING FROM THE INSTRUMENT MATERIAL. REVIEW OF INTERNAL DOCUMENTS THE INSTRUMENT MATERIAL IS IN ACCORDANCE TO ISO 7153-1, ISO 16061, EN 10088-1, EN 10088-2, EN 10088-3, AND ASTM F899. INSTRUMENT CLEANING IS DESCRIBED IN MANUAL ORTHOPAEDIC SURGICAL INSTRUMENTS. 1. POSSIBLE CAUSES FOR THE REPORTED EVENT ACCORDING TO DFMEA A) LINE 7: DISCOLORATION/CORROSION FOUND ON THE INSTRUMENTS DUE TO IMPROPER CHOICE OF STERILIZATION METHOD/CYCLE. B) LINE 9: DISCOLORATION/CORROSION FOUND ON THE INSTRUMENTS DUE TO INADEQUATE CLEANING METHOD, INCORRECT CLEANING AGENTS USED. C) LINE 15: DISCOLORATION/CORROSION FOUND ON THE INSTRUMENTS DUE TO CORROSION PRODUCTS PRESENT ON INSTRUMENT. 2. COMPARISON TO INVESTIGATION RESULTS WHETHER IT IS POSSIBLE & JUSTIFICATION: A) POSSIBLE: AFTER THE STANDARD DECONTAMINATION PROCEDURE PERFORMED AT ZIMMER BIOMET, ONLY THE NAIL AND THE TARGETING GUIDE WAS SHOWING CORROSION TRACES. THE VISUAL EXAMINATION OF THE PARTS REVEALED CORROSION ON AROUND THE SPHERES AND PLUGS IN DIVERSE PLACES ON THE INSTRUMENTS. THE RECEIVED PARTS WERE PHOTOGRAPHED AND THEN CLEANED BY A STANDARD RUST REMOVAL AGENT (DECONNEX). AFTER THE CLEANING WITH THE RUST REMOVAL AGENT THE CORROSION ON THE INSTRUMENT DIMINISHED. THIS WAS DOCUMENTED IN PHOTOGRAPHS. AFTERWARD, A CORROSION TEST WAS PERFORMED ON THE INSTRUMENTS. THE INSTRUMENTS WERE SET FOR 45 MINUTES IN A SOLUTION. AFTER THE TEST NO NEW CORROSION WAS FORMED. THIS MEANS THAT THE CORROSION IS NOT ORIGINATING FROM THE INSTRUMENT MATERIAL. B) POSSIBLE: AFTER THE STANDARD DECONTAMINATION PROCEDURE PERFORMED AT ZIMMER BIOMET, ONLY THE NAIL AND THE TARGETING GUIDE WAS SHOWING CORROSION TRACES. THE VISUAL EXAMINATION OF THE PARTS REVEALED CORROSION ON AROUND THE SPHERES AND PLUGS IN DIVERSE PLACES ON THE INSTRUMENTS. THE RECEIVED PARTS WERE PHOTOGRAPHED AND THEN CLEANED BY A STANDARD RUST REMOVAL AGENT (DECONNEX). AFTER THE CLEANING WITH THE RUST REMOVAL AGENT THE CORROSION ON THE INSTRUMENT DIMINISHED. THIS WAS DOCUMENTED IN PHOTOGRAPHS. AFTERWARD, A CORROSION TEST WAS PERFORMED ON THE INSTRUMENTS. THE INSTRUMENTS WERE SET FOR 45 MINUTES IN A SOLUTION. AFTER THE TEST NO NEW CORROSION WAS FORMED. THIS MEANS THAT THE CORROSION IS NOT ORIGINATING FROM THE INSTRUMENT MATERIAL. C) NOT POSSIBLE: THE INVESTIGATION SHOWED THAT THE CORROSION WAS NOT ORIGINATING FROM THE INSTRUMENT MATERIAL ITSELF. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE COULD IDENTIFY A ROOT CAUSE FOR THIS ISSUE. THE INVESTIGATION SHOWED THAT THE CORROSION WAS NOT ORIGINATING FROM THE INSTRUMENT MATERIAL ITSELF. THE DISCOLORATION ON THE INSTRUMENTS MUST HAVE OCCURRED DUE TO STERILIZED WITH UNDEFINED STERILIZATION CONFIGURATION(E.G.,MIXED ITEMS) OR INADEQUATE CLEANING METHOD (INCORRECT CLEANING AGENTS USED). IT IS POSSIBLE THAT THE RUST HAS BEEN DEPOSITED FROM OTHER INSTRUMENTS. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. DHR REVIEW: DHR RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. TREND ANALYSIS: NO TREND IDENTIFIED. COMPATIBILITY CHECK THE COMPATIBILITY CHECK COULD NOT BE PERFORMED AS ONLY ONE PRODUCT WAS REPORTED TO US. THE PRODUCT COMPATIBILITY CHECK IS NOT RELEVANT FOR ONE PRODUCT ONLY. THE AFFECTED PRODUCTS WERE NOT USED IN THE SAME SURGERY. REVIEW OF INCOMING INFORMATION: IT IS REPORTED THAT THE INSTRUMENTS PRESENTS MASSIVE RUST AFTER CLEANING. 5 PICTURES WERE AVAILABLE FOR INVESTIGATION, SHOWING STAINING OR "INCRUSTATION" ON THE INSTRUMENTS. NO OTHER DOCUMENTS WERE PROVIDED. REVIEW OF INTERNAL DOCUMENTS: INSPECTION PLAN: VISUAL INSPECTION PERFORMED AQL 0.65%. THE INSTRUMENT MATERIAL IS IN ACCORDANCE TO STANDARDS. INSTRUMENT CLEANING IS DESCRIBED IN MANUAL ORTHOPAEDIC SURGICAL INSTRUMENTS. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE COULD IDENTIFY A ROOT CAUSE FOR THIS ISSUE. DEDUCTED FROM THE EVENT DESCRIPTION AND AFTER PICTURES EXAMINATION THE FOUND ISSUE IS CAUSED BY STAINING. STAINING IS A SURFACE DEPOSIT ON INSTRUMENTS THAT IS MOST OFTEN MISTAKEN FOR RUST. STAINING AND WATER SPOTS WERE FOUND ON THE INSTRUMENTS DUE TO IMPROPER CLEANING CYCLE. WATER SPOTS CAN BE CAUSED BY A TOO HIGH CONCENTRATION OF CLEANING AGENTS OR MINERALS OR ORGANIC RESIDUALS. THE USE OF CITY WATER DURING THE WASHING AND STERILIZATION PROCESS ALSO PRODUCES FLECKS. GENERALLY, PURIFIED WATER SHOULD BE USED IN THE LAST TWO RINSE STEPS BY WASHING AND IN THE AUTOCLAVE PROCESS. ALSO OVERLOADED INSTRUMENT TRAYS IN THE AUTOCLAVE OR INSTRUMENT CONTACT SURFACES CAN CAUSE WATER SPOTS. ORANGE/BROWN STAIN: THE PROBLEM IS MOST OFTEN A PHOSPHATE LAYER (BROWN TO LIGHT ORANGE) ON THE INSTRUMENT, WHICH DEVELOPS AS A RESULT OF ANY OF THE FOLLOWING CAUSES: WATER SOURCES, DETERGENTS USED TO WASH AND CLEAN INSTRUMENTS, SURGICAL WRAPPINGS, COLD STERILIZATION SOLUTIONS, OR DRIED BLOOD. 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 MFR DID NOT RECEIVE DEVICES FOR REVIEW BUT IT IS MENTIONED THAT THEY WILL BE RETURNED. PICTURES OF THE DEVICES WERE REC'D. WHERE LOT NUMBERS WERE REC'D FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. AS SOON AS ADDITIONAL INFORMATION BECOMES 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 MASSIVE CORROSION WAS DETECTED ON TWO INSTRUMENTS CM ANTIROTATION PIN SLEEVE 3.0 MM DURING CLEANING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520030 CM ANTIROTATION PIN SLEEVE 3.0 MM ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDU HSB ZIMMER GMBH NA 13766432

    Patients

    Seq Age Sex Outcome Treatment
    1 Other