BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING HOLDING SLEEVE-LONG FOR MATRIX

    MDR report key: 3829134 · Received May 23, 2014

    Report

    Report Number
    1719045-2014-10226
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    May 6, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED: RMS COMPANY MANUFACTURED THE LOCKING HOLDING SLEEVE ¿ LONG FOR MATRIX. THE SUPPLIER¿S CERTIFICATE OF COMPLIANCE INDICATES THE PARTS WERE MANUFACTURED TO AND MET THE REQUIRED SPECIFICATIONS. THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES, TABULATED INCOMING FINAL INSPECTION SHEET. THERE WERE NO MATERIAL REVIEW REPORTS, NON-CONFORMANCE REPORTS, OR COMPLAINT RELATED ISSUES WITH THIS COMPLAINT. 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

    A MANUFACTURING INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT THE: RMS COMPANY MANUFACTURED THE LOCKING HOLDING SLEEVE, P/N 03.616.043, ON LOT NUMBER 6921274 ON PO #1373984 FOR (B)(4) PIECES DELIVERED OCTOBER 29, 2012. INITIALLY, THE PARTS CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE, DATED OCTOBER 25, 2012, AND TO SYNTHES FINAL INSPECTION SHEET # NS054040, REVISION ¿D¿. THE PARTS WERE RELEASED TO THE WAREHOUSE ON DECEMBER 5, 2012. DUE TO AN UNKNOWN CAUSE, THE MATRIX SCREW HOLDER BROKE DURING SURGERY. ALL FRAGMENTS WERE RETRIEVED. THIS INSTRUMENT BELONGS TO A LOAN SET WHICH IS PLACED AT THE HOSPITAL. BASED ON THE EVALUATION AND THE UNKNOWN CAUSE, THIS COMPLAINT IS CONSIDERED CONFIRMED BUT IS NOT MANUFACTURING-RELATED. THERE WERE NO MRR¿S, NCR¿S, OR COMPLAINT RELATED ISSUES WITH THIS LOT. THE LOCKING HOLDING SLEEVE WAS MADE TO THE SYNTHES DRAWING P/N 03.616.042, REVISION ¿D¿, RELEASED ON APRIL 18, 2012. 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 (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE MATRIX SCREW HOLDER BROKE DURING SURGERY. ALL FRAGMENTS WERE RETRIEVED. THERE WAS NO REPORTED HARM TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307695 LOCKING HOLDING SLEEVE-LONG FOR MATRIX MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT 6921274

    Patients

    Seq Age Sex Outcome Treatment
    1