BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONICAL EXTRACTION SCREW

    MDR report key: 3752210 · Received April 15, 2014

    Report

    Report Number
    1719045-2014-10144
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 27, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FSM
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITION MANUFACTURE RELEASED DATE OF 4/21/2006. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND REPORTED UNIQUE INSTRUMENTS (PRESENTLY ORCHID UNIQUE) MANUFACTURED THE CONICAL EXTRACTION SCREW, P/N 387.34, AND LOT NUMBER UQ56653 FOR POS 619278 AND 637671. THE SUPPLIER¿S CERTIFICATES OF COMPLIANCE (DATED (B)(4) 2006 FOR 2 RECEIPTS OF THIS LOT) INDICATE THE PARTS WERE MANUFACTURED TO P/N 387.34 AND MET THE REQUIRED SPECIFICATIONS. THE PARTS WERE INSPECTED AND CONFORMED TO THE SYNTHES, INCOMING FINAL INSPECTION SHEET NUMBER 292IF625, REVISION ¿E¿ (COMPLETED 3/2/06 AND 4/21/06). NO MANUFACTURING ISSUES OR NON-CONFORMANCES WERE GENERATED FOR THIS LOT.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS COMPLETED: UNIQUE INSTRUMENTS INC. MANUFACTURED THE CONICAL EXTRACTION SCREW, PART NUMBER 387.34 AND LOT NUMBER UQ56653. DUE TO AN UNKNOWN CAUSE, THE TIP OF THE SCREW BROKE OFF DURING SCREW EXTRACTION. INITIALLY, THE PART CONFORMED TO THE CERTIFICATES OF COMPLIANCE. BASED ON THE EVALUATION AND THE UNKNOWN CAUSE, THIS COMPLAINT IS NOT MANUFACTURING-RELATED AND IS CONSIDERED UNCONFIRMED. THE CONICAL EXTRACTION SCREW WAS MADE TO THE RELEVANT SYNTHES DRAWING. 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

    IT WAS REPORTED THAT DURING A ANTERIOR CERVICAL FUSION PROCEDURE, THE SURGEON WAS TRYING TO REMOVE SCREW AFTER IT BECAME STRIPPED, WHILE ATTEMPTING TO REMOVE THE SCREW, 3 CONICAL EXTRACTION SCREWS BROKE APART. ALL BROKEN FRAGMENTS WERE RECOVERED. THERE WAS A 30 MINUTE OPERATIVE DELAY. THE SURGEON WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO PATIENT INJURY REPORTED. THIS IS REPORT 1 OF 4 FOR COM (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229859 CONICAL EXTRACTION SCREW TRAY,SURGICAL INSTRUMENT FSM SYNTHES MONUMENT UQ56653

    Patients

    Seq Age Sex Outcome Treatment
    1