BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9MM TI CANNULATED TIBIAL NAIL-EX/270MM-STERILE

    MDR report key: 4762690 · Received May 11, 2015

    Report

    Report Number
    1000562954-2015-10099
    Event Type
    Injury
    Date Received
    May 11, 2015
    Date of Event
    April 20, 2015
    Report Date
    April 21, 2015
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    JDS
    PMA / PMN Number
    PK040762
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: MANUFACTURING INVESTIGATION EVALUATION: RECEIVED ONE NAIL IN THE ORIGINAL STERILE PACKAGING. THE NAIL IS LIGHT GREEN AND ETCHED AS ART. 04.004.334/ LOT#3006566. THE RE-INSPECTION OF THE PART RETURNED CONFIRMED THAT THE INVOLVED ITEM IS 04.004.334 (EXPERT TN Ø9), CORRECTLY ETCHED AND PACKAGED BUT THE COLOR OF THE NAIL IS OUT OF SPECIFICATION (NAIL IS ANODIZED LIGHT GREEN INSTEAD OF BLUE). CONSIDERING THAT THE ANODIZING PROCESS IS A BATCH PROCESS AND NO REWORKS ARE DOCUMENTED FOR THE LOT 3006566, WE CONSIDER THE WHOLE LOT 3006566 ((B)(4) PIECES) INVOLVED IN THE ISSUE. THE INVOLVED LOT WAS MANUFACTURED IN 2008 (ANODIZING PERFORMED IN HOUSE THROUGH MFA EQUIPMENT). THE MOST PROBABLE PRELIMINARY ROOT CAUSE IS THAT: THE ANODIZING PROGRAM HAS BEEN WRONGLY SELECTED BY THE OPERATOR WHO LOADED THE PIECES ON THE ANODIZING FIXTURE/RACK. ANODIZING WAS PERFORMED IN HOUSE IN (B)(6) 2008 THROUGH MFA EQUIPMENT WHEN THE BARCODE CHARGING SYSTEM WAS NOT YET IN PLACE: ANODIZING PROGRAM CHARGED MANUALLY. THE ISSUE HAS NOT BEEN IDENTIFIED DURING THE UNLOADING OF THE PIECES AFTER THE ANODIZING PROCESS AND IT HAS ALSO NOT BEEN IDENTIFIED AT FINAL INSPECTION AFTER THE ANODIZING PROCESS PERFORMED ACCORDING INSPECTION SHEET. CONSIDERING THAT THE FIXTURE/RACK IN USE ON THE ANODIZING EQUIPMENT ALLOWED TO CHARGE MAXIMUM (B)(4) NAILS, NO OTHER LOTS WERE CHARGED ON THE SAME FIXTURE/RACK TOGETHER WITH THE PIECES OF THE LOT 3006566. NO EVIDENCE OF OTHER LOTS INVOLVED IN THE ISSUE. CONSIDERING THE RESULTS OF THE INVESTIGATION PERFORMED, THE BOUNDING OF THE ISSUE HAS BEEN IDENTIFIED IN THE WHOLE NOT STERILE LOT#3006566 (QTY (B)(4) PCS)/ ART 04.004.334 WHICH HAVE BEEN STERILE REPROCESSED AN DISTRIBUTED AS ART 04.004.334S/ LOT#3018420 AND LOT#3405573. GLOBAL STOP SHIPMENT INITIATED ON MAY 8, 2015 ON THE TWO STERILE LOTS (LOT3018420 AND LOT3405573) ORIGINATED FROM THE NOT STERILE LOT NUMBER INVOLVED IN THE ISSUE (LOT3006566). DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: YEAR OF BIRTH REPORTED AS 1974; DAY AND MONTH UNKNOWN. WEIGHT IS UNKNOWN. DEVICE WAS NOT IMPLANTED/EXPLANTED. THIS COMPLAINT IS ASSESSED AS NOT RELATED TO STERILIZATION. THUS, THE DOCUMENTS FOR THE CORRESPONDING NON STERILE PART 04.004.334 LOT 3006566 WERE REVIEWED WITH THE FOLLOWING RESULT: NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE 9 MM TIBIAL NAIL WAS THE WRONG COLOR. WHEN UNPACKING THE STERILE 9 MM NAIL IT WAS GREEN AND NOT BLUE; THE NAIL DOES SAY 9MM WHICH IS CORRECT. THE SURGEON TRIED TO USE THE CORRESPONDING GREEN SCREWS, DRILL, ETC. THE SCREWS DID NOT FIT THE NAIL. AFTER A WHILE THE WRONG COLOR CODE OF THE NAIL WAS DISCOVERED AND THE WRONG NAIL HAD TO BE REMOVED AGAIN. A NEW BLUE 9 MM NAIL WAS UNPACKED AND THE SURGERY CONTINUED WITH THE RIGHT BLUE SCREWS AND DRILL BITS. THE OPERATION WAS EXTENDED FOR NINETY MINUTES DUE TO THIS ERROR. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307858 9MM TI CANNULATED TIBIAL NAIL-EX/270MM-STERILE NAIL, FIXATION, BONE JDS SYNTHES MEZZOVICO 3405573

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention