BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE-LONG FOR MATRIX

    MDR report key: 3981302 · Received August 5, 2014

    Report

    Report Number
    1719045-2014-10353
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 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

    A MANUFACTURING EVALUATION WAS COMPLETED: AVALIGN TECHNOLOGIES-NEMCOMED MANUFACTURED THE HOLDING SLEEVE-LONG FOR MATRIX, PART NUMBER 03.632.036, AND LOT 6972479. INITIALLY, THE PART CONFORMED TO THE CERTIFICATE OF COMPLIANCE AND WAS INSPECTED AND CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET. DUE TO AN UNKNOWN CAUSE, DURING INSERTION OF PEDICLE SCREW THE RETAINING SLEEVE SEEMED TO DETACH FROM THE SCREW. IT WAS NOTICED BY THE SURGEON THAT PART OF THE TIP OF THE SLEEVE HAD BROKEN OFF AND THEREFORE WAS UNABLE TO THREAD IN TO THE HEAD OF THE PEDICLE SCREW. THE SCREW WAS RE-INSERTED WITH A SPARE RETAINING SLEEVE AND THE OPERATION CONTINUED WITHOUT FURTHER INCIDENT. THE PATIENT RECEIVED NO INJURY. BASED ON THE EVALUATION AND THE UNKNOWN CAUSE, THIS COMPLAINT IS CONSIDERED CONFIRMED BUT IS NOT MANUFACTURING RELATED. ALL MEASURABLE DIMENSIONS PASSED, BUT DUE TO THE DAMAGE TO THE DEVICE, NOT ALL DIMENSIONS COULD BE MEASURED. THERE WERE NO MATERIAL REVIEW REPORTS, NON-CONFORMANCE REPORTS, OR COMPLAINT RELATED ISSUES WITH THIS LOT. 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. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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 REPORTS THAT DURING THE INSERTION OF PEDICLE SCREW THE RETAINING SLEEVE SEEMED TO DETACH FROM THE SCREW. IT WAS NOTICED BY THE SURGEON THAT PART OF THE TIP OF THE SLEEVE HAD BROKEN OFF AND THEREFORE WAS UNABLE TO THREAD IN TO THE HEAD OF THE PEDICLE SCREW. THE SCREW WAS RE-INSERTED WITH A SPARE RETAINING SLEEVE AND THE OPERATION CONTINUED WITHOUT FURTHER INCIDENT. THERE WAS NO PATIENT HARM OR ANY REPORT OF A SURGICAL DELAY. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457926 HOLDING SLEEVE-LONG FOR MATRIX MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT 6972479

    Patients

    Seq Age Sex Outcome Treatment
    1