BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING HOLDING SLEEVE-LONG FOR MATRIX

    MDR report key: 5323240 · Received December 23, 2015

    Report

    Report Number
    1719045-2015-10849
    Event Type
    Malfunction
    Date Received
    December 23, 2015
    Report Date
    October 30, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE FOR REPORTING DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). DEVICE INVESTIGATION SUMMARY ¿THE LOCKING HOLDING SLEEVE-LONG FOR MATRIX ONE OF FIVE HOLDINGS SLEEVES AVAILABLE FOR SCREW INSERTION IN THE MATRIX SYSTEM. THE RETURNED INSTRUMENT WAS EXAMINED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE THREADED TIP OF THE HOLDING SLEEVE WAS BROKEN AND MISSING A SEGMENT. THE REMAINDER OF THE DEVICE SHOWED WITNESS MARKS CONSISTENT WITH USE: SCRATCHED FINISH, WORN THREADS. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED HOWEVER THE FAILURE MODE IS CONSISTENT WITH ROUGH HANDLING AND/OR THE APPLICATION OF OFF-AXIS LOADING FOR A MULTI-USE DEVICE WITH 3+ YEARS IN THE FIELD. RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED INSTRUMENT¿S LOT NUMBERS AND IN EACH INSTANCE NO MRRS, NCRS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOTS NUMBERS WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DHR REVIEW ¿ PART NUMBER: 03.616.043. LOT NUMBER: 6921274. RELEASE TO WAREHOUSE DATE: DECEMBER 5, 2012. MANUFACTURING SITE IS SYNTHES (B)(4) AND SUPPLIED BY (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS INITIALLY REPORTED THAT A LOCKING HOLDING SLEEVE-LONG FOR MATRIX (03.616.043 LOT 6921274) HAD "DESTROYED" THREADS. UPON RECEIPT OF THE DEVICE, THE RETURNED INSTRUMENT WAS EXAMINED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE THREADED TIP OF THE HOLDING SLEEVE WAS BROKEN AND MISSING A SEGMENT; THE FRAGMENT NOT RETURNED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847742 LOCKING HOLDING SLEEVE-LONG FOR MATRIX MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT 6921274

    Patients

    Seq Age Sex Outcome Treatment
    1