BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM TI VA LOCKING SCREW STARDRIVE 16MM-STERILE

    MDR report key: 8901664 · Received August 16, 2019

    Report

    Report Number
    8030965-2019-67351
    Event Type
    Malfunction
    Date Received
    August 16, 2019
    Date of Event
    July 11, 2019
    Report Date
    July 18, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    UDI-DI
    07611819980655
    PMA / PMN Number
    K102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY LOT. THIS MRE REVIEW IS FOR STERILIZATION PROCEDURE ONLY. PART: 04.210.116S; LOT: L023946; MANUFACTURING SITE: SELZACH ; SUPPLIER: FRÜH VERPACKUNGSTECHNIK AG ; RELEASE TO WAREHOUSE DATE: 20.JUNE 2016; EXPIRY DATE: 01.JUNE 2026. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. NON-STERILE PART WAS MANUFACTURED IN MONUMENT PART: 04.210.116 LOT: H031109 MANUFACTURING LOCATION: SUPPLIER ¿ MARK TWO ENGINEERING / INSPECTED, PACKAGED AND RELEASED BY: MONUMENT RELEASE TO WAREHOUSE DATE: 18-MAY-2016 PART NUMBER: 04.210.116, 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM LOT NUMBER: H031109 (NON-STERILE) COMPONENT PART(S) REVIEWED: PAT NUMBER: 21015, TIALNBRI4.00 LOT NUMBER: 9955088 THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, A SURGERY FOR HALLUX VALGUS OF THE RIGHT METATARSAL BONE WAS PERFORMED WITH VA X-PLATE (SMALL) AND THE LOCKING SCREW IN QUESTION. WHEN THE SURGEON WAS INSERTING THE LOCKING SCREW FROM DESIRED ANGLE, A BURR WAS GENERATED FROM RIGHT UNDER THE SCREW HEAD. HE USED ANOTHER SCREW AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. THE SURGEON COMMENTED THAT THE SCREW INSERTION MIGHT HAVE BEEN TOO ANGLED AND IT GENERATED THE BURR. THE ALERT DATE IS JULY 18, 2019 (JST). NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN VARIABLE ANGLE X-PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY #: 1). THIS REPORT IS FOR ONE (1) 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM-STERILE THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697121 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM-STERILE PLATE,FIXATION,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH L023946 07611819980655

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - PLATES