BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM IMF SCREW SELF-DRILLING 8MM-STERILE

    MDR report key: 6574254 · Received May 17, 2017

    Report

    Report Number
    3000270450-2017-10167
    Event Type
    Malfunction
    Date Received
    May 17, 2017
    Date of Event
    April 15, 2017
    Report Date
    April 20, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    DZL
    PMA / PMN Number
    K010527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. UDI: (B)(4) TWO LOT NUMBERS WERE REPORTED, IT IS NOT KNOWN WHICH ONE IS CORRECT FOR THIS DEVICE. LOT NUMBER IS EITHER L348043 OR L187571. DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. HOSPITAL CONTACT TELEPHONE: (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF CORRECT LOT IS L348043, THEN MANUFACTURE DATE IS MARCH 20, 2017. IF CORRECT LOT IS L187571, THEN MANUFACTURE DATE IS NOVEMBER 7, 2016. LOT L348043 . DEVICE WAS FIRST MANUFACTURED UNSTERILE UNDER THE LOT L288684 IN (B)(4) AND STERILIZED AFTERWARDS. AS THIS COMPLAINT IS NEITHER PACKAGING NOR STERILIZATION RELATED ONLY THE MANUFACTURING DOCUMENTS OF THE UNSTERILE DEVICE 201.928 WITH LOT L288684 WERE REVIEWED: THE REVIEW HAS SHOWN THAT NR-0060532 WAS OPENED FOR THIS LOT, THEREFORE AN DHR REVIEW TASK WILL BE ASSIGNED TO (B)(4) FOR THE DHR REVIEW. MANUFACTURING SITE: (B)(4). SUPPLIER: (B)(4). MANUFACTURING DATE: 20. MAR. 2017. EXPIRY DATE: 01. MAR. 2027. LOT L187571. DEVICE WAS FIRST MANUFACTURED UNSTERILE UNDER THE LOT L178481 IN (B)(4) AND STERILIZED AFTERWARDS. AS THIS COMPLAINT IS NEITHER PACKAGING NOR STERILIZATION RELATED ONLY THE MANUFACTURING DOCUMENTS OF THE UNSTERILE DEVICE 201.928 WITH LOT L178481 WERE REVIEWED: NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. MANUFACTURING SITE: (B)(4). SUPPLIER: (B)(4). MANUFACTURING DATE: 07. NOV. 2016. EXPIRY DATE: 01. OCT. 2026. NOT STERILE LOT#288684. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 07 MAR 2017. THE DHR OF THE INVOLVED NOT STERILE LOT#288684 HAS BEEN REVIEWED. LOT#288684 WAS TURNED ON 24 JAN 2017 STARTING FROM THE RAW MATERIAL LOT#17662. THE CERTIFICATE OF THE RAW MATERIAL FOR LOT#17662 HAS BEEN REVIEWED: IN THE CERTIFICATE IT IS REPORTED THAT THE MATERIAL FULFILLS THE SPECIFICATION. ALL THE INSPECTIONS ON LOT#288684 DOCUMENTED IN THE INSPECTION SHEET ATTACHED TO DHR PASSED BUT THE INSPECTION OF THE EXTERNAL DIAMETER OF THE THREAD PERFORMED AT FINAL INSPECTION HAVE NOT BEEN DOCUMENTED. THIS ISSUE HAS BEEN INTERNALLY IDENTIFIED AT LOT RELEASE STEP ON 30 JAN 2017 AS DOCUMENTED ON THE DHR DOCUMENTATION ERROR COMMUNICATION FORM ATTACHED TO DHR, AND THE ISSUE HAS BEEN ADDRESSED TO THE NR-0060532 ALREADY IN PLACE FOR DOCUMENTATION ISSUE (EMPTY FIELD ON DOCUMENTATION). NR-0060532 IS NOT RELEVANT TO THE COMPLAINT CONDITION BECAUSE IT¿S ABOUT A DOCUMENTATION ISSUE WITH NO RELATIONSHIP TO THE BREAKAGE DOCUMENTED IN THE COMPLAINT REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 EUROPE REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN SURGICAL PROCEDURE ON (B)(6) 2017, TWO (2) INTERMAXILLARY FIXATION (IMF) SCREWS BROKE. THE TIPS OF THE BROKEN SCREWS WERE NOT RETRIEVED AND REMAIN EMBEDDED IN PATIENT BONE. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 5 MINUTES BUT NO HARM TO PATIENT. THIS REPORT IS FOR ONE (1) 2.0MM IMF SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353747 2.0MM IMF SCREW SELF-DRILLING 8MM-STERILE SCREW FIXATION INTRAOSSEOUS DZL SYNTHES SELZACH

    Patients

    Seq Age Sex Outcome Treatment
    1