BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAXICAN TI SCREW CAN 45X55 MM PT THD

    MDR report key: 4995417 · Received August 10, 2015

    Report

    Report Number
    9613350-2015-00972
    Event Type
    Other
    Date Received
    August 10, 2015
    Date of Event
    June 11, 2015
    Report Date
    July 18, 2015
    Manufacturer
    NORMED MEDIZIN-TECHNIK GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER RECEIVED THE DEVICE AND INVESTIGATION IS ONGOING. A LOT NUMBER WAS RECEIVED FOR THE DEVICE, THE DEVICE HISTORY RECORDS WILL BE REVIEWED AS PART OF THE INVESTIGATION PROCESS. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. AS SOON AS ADDITIONAL INFO 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).

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS WERE MADE AVAILABLE. NO TREND WAS IDENTIFIED. IT WAS REPORTED THAT THE DEVICE HAD A WRONG LABEL AND A WRONG LASER MARK. VISUAL EXAMINATION OF THE RETURNED DEVICE: RETURNED PRODUCT WAS PACKED IN AN RE-CLOSED PACKAGE LABELED WITH: 515018070, LOT 14649 "CBS MICRO COMPRESSION SCREW 18 MM, CANNULATED". ON THE RETURNED GREEN SCREW THERE IS NO REFERENCE NUMBER LASER MARKING, BUT THE LOT NUMBER 12508 IS LASERED, WHICH IS UNIQUE AND GIVES THE TRACEABILITY. ADDITIONALLY, THE SCREW IS LASERED WITH THE MARK "55 MM". MEASUREMENTS: THE SCREW IS 60 MM LONG, CANNULATED. THE SCREWDRIVER DIAMETER IS ACCORDING TECHNICAL DRAWING. THE LOT NUMBER 12508 BELONGS TO THE REFERENCE NUMBER 28.24.055. THE "055" INDICATES THAT THE SCREW SHOULD BE 55 MM LONG. THE SCREW IS IN FACT 60 MM LONG; THIS LENGTH CORRESPONDS TO A DIFFERENT PRODUCT WITH REFERENCE NUMBER 28.24.060. DHR REVIEW RESULTS FOR LOT#12508, (B)(4): YIELD: (B)(6) PIECES. DELIVERED: (B)(6) PIECES. RELEASE DATE: (B)(6) 2013. SCRAPPED PRODUCTS: - THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. POSSIBLE CAUSE FOR THE REPORTED EVENT ACCORDING PFMEA: MIX-UP DURING MANUFACTURING PROCESS BY NORMED. PARTS WERE COMMINGLED. THEREFORE, THE PARTS WERE WRONG LASER MARKED AND LABELED. IT IS POSSIBLE THAT ONE 60 MM SCREW WAS DELIVERED BY THE SUPPLIER AS 55MM SCREWS AND THIS LED TO THE MISLABELING OF THE SCREW. THE COMPLAINED SCREW WAS ENGRAVED WITH THE LOT NUMBER AND LENGTH OF THE SHORTER SCREW (55 MM INSTEAD OF 60MM). THE SCREWS OF LENGTH 60 MM AND 55MM ARRIVED ON (B)(6) 2013 AND ON (B)(6) 2013 AT NORMED AS SEMI-FINISHED GOODS. AFTER INCOMING INSPECTION, THE DEVICES WERE LASER MARKED AND PACKAGED AT (B)(4). BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. THE INVESTIGATION LED TO THE RESULT THAT THE SCREW OF 55MM AND 60 MM WERE MANUFACTURED APPROXIMATELY AT THE SAME TIME. THIS MAY HAVE CONTRIBUTED AND CAUSED THE MISLABELING DUE TO SUPPLY ERROR OR INSUFFICIENT LINE CLEARANCE. A CORRECTIVE AND PREVENTIVE ACTION HAS BEEN INITIATED AT NORMED. A HEALTH HAZARD EVALUATION HAS BEEN PERFORMED AND A FIELD SAFETY CORRECTIVE ACTION IS GOING TO BE INITIATED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DISTRIBUTOR THAT THE (B)(4) TI SCREW CANN 45X55 MM PT THD IS INCORRECT ABOUT MEASURES AND MARK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522513 MAXICAN TI SCREW CAN 45X55 MM PT THD NORMED TITANIUM OSTEOTOMY PLATING SYSTEM HRS NORMED MEDIZIN-TECHNIK GMBH NA 12508/269A13

    Patients

    Seq Age Sex Outcome Treatment
    1 Other