BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE COUPLING SCREW

    MDR report key: 4181270 · Received October 17, 2014

    Report

    Report Number
    1719045-2014-10515
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    September 22, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: PER THE TECHNIQUE GUIDE, THE HELICAL BLADE COUPLING SCREW IS PART OF TITANIUM TROCHANTERIC FIXATION NAIL (TFN) SYSTEM AND IT IS USED IN THE INSERTION OF THE HELICAL BLADE DURING TFN PROCEDURE. ONE HELICAL BLADE COUPLING SCREW (PART 357.377, LOT IS10346, MANUFACTURED NOVEMBER 2009) WAS RETURNED. UPON RECEIPT OF THIS DEVICE IT WAS FOUND THAT THE COUPLING SCREW IS IN OVERALL GOOD CONDITION, IT SHOWS SIGNS OF HEX DRIVE WEAR, DISCOLORATION ALONG THE TUBE LENGTH, FROM USE AND REPROCESSING BUT IS NOT DAMAGED. THE RETURNED DEVICE WAS ASSEMBLED INTO THE HELICAL BLADE INSERTER 357.372 AND THREADED INTO THE HELICAL BLADE 456.302 AND THERE WERE NO ISSUES ENCOUNTERED DURING THE ASSEMBLY AND THREADING PROCESS. THE RELEVANT DRAWINGS WERE REVIEWED, AND SINCE THE RETURNED DEVICE WAS ABLE TO THREAD INTO THE HELICAL BLADE INSERTER WITH NO ISSUES THIS COMPLAINT IS UNCONFIRMED AND THE DESIGN OF THE DEVICE DID NOT CONTRIBUTE TO THIS COMPLAINT. THIS COMPLAINT CONDITION IS UNCONFIRMED; THE DESIGN OF THIS DEVICE IS ADEQUATE FOR ITS INTENDED USE AND DID NOT 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.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED. 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

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT ISIMAC MACHINE COMPANY MANUFACTURED THE HELICAL BLADE COUPLING SCREW, P/N 357.377, AND LOT NUMBER IS10346 ON PO #1055988, FOR 61 PIECES DELIVERED NOVEMBER 23, 2009. INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE, DATED NOVEMBER 18, 2009, AND SYNTHES FINAL INSPECTION SHEET # NS024218, REVISION ¿A¿. THE PARTS WERE RELEASED TO THE WAREHOUSE ON NOVEMBER 24, 2009. THERE WERE NO MRR¿S, NCR¿S, OR COMPLAINT RELATED ISSUES WITH THIS LOT. THE HELICAL BLADE COUPLING SCREW WAS MADE TO THE SYNTHES DRAWING P/N 357.377, REVISION ¿J¿, RELEASED ON DECEMBER 17, 2007. 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 DURING ROUTINE MAINTENANCE INSPECTION THAT THE TITANIUM TROCHANTERIC FIXATION NAIL WAS NOT ALLOWING "SCREWDRIVER", TO INSERT. THERE WAS NO PATIENT INVOLVED. THIS IS REPORT NUMBER 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660763 HELICAL BLADE COUPLING SCREW MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES MONUMENT IS10346

    Patients

    Seq Age Sex Outcome Treatment
    1