BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE-LONG FOR MATRIX

    MDR report key: 4097799 · Received September 18, 2014

    Report

    Report Number
    1719045-2014-10447
    Event Type
    Malfunction
    Date Received
    September 18, 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 DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT MAGNUM MANUFACTURING. MANUFACTURED THE HOLDING SLEEVE, P/N 03.632.036, AND LOT NUMBER 6703412 ON PO #1275936 FOR 39 PIECES DATED DECEMBER 2, 2011 AND FOR 11 PIECES DATED FEBRUARY 28, 2012. INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE, DATED DECEMBER 2, 2011 (39 PIECES) AND FEBRUARY 15, 2012 (11 PIECES), AND TO THE SYNTHES FINAL INSPECTION SHEET # NS035211, REVISION ¿P¿. THE PARTS WERE RELEASED TO THE WAREHOUSE ON DECEMBER 12, 2011 (39 PIECES) AND MARCH 6, 2012 (11 PIECES). THERE WERE NO MRR¿S, NCR¿S, OR COMPLAINT RELATED ISSUES WITH THIS LOT. THE HOLDING SLEEVE WAS MADE TO THE SYNTHES DRAWING P/N 03.632.001, REVISION ¿J¿, RELEASED ON 7/12/2011. 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED 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. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577975 HOLDING SLEEVE-LONG FOR MATRIX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNTHES MONUMENT 6703412

    Patients

    Seq Age Sex Outcome Treatment
    1