BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE-LONG FOR MATRIX

    MDR report key: 6195720 · Received December 21, 2016

    Report

    Report Number
    1719045-2016-10944
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Report Date
    November 30, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    UDI-DI
    07611819379435
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. EVENT DATE: UNKNOWN. IMPLANT AND EXPLANT DATES: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. CONCOMITANT PRODUCT(S): THERAPY DATE UNKNOWN. INITIAL REPORTER PHONE NUMBER (B)(6). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. PART #03.632.036, LOT # 6972479 RELEASE TO WAREHOUSE DATE: 6-NOV-2012, 15-NOV-20012, 5-JUN-2013. SUPPLIER: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    SYNTHES (B)(4) REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE THREADED PORTION OF TWO RETAINING SLEEVES BROKE OFF DURING SURGERY. DATE OF SURGERY IS UNKNOWN. THE MALFUNCTIONS WERE DISCOVERED WHEN NEW SCREWS COULD NOT BE LOADED IN THE SLEEVES. IT IS UNKNOWN IF THE THREADED PORTIONS BROKE OFF IN THE SCREWS. IT IS UNKNOWN IF ALL BROKEN FRAGMENTS WERE REMOVED. A STARDRIVE T25 WAS USED TO PROCEED WITH SURGERY. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY OR PATIENT HARM. PATIENT OUTCOME WAS REPORTED AS GOOD. CONCOMITANT DEVICES REPORTED: SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). THIS IS REPORT NUMBER 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845468 HOLDING SLEEVE-LONG FOR MATRIX MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT 6972479 07611819379435

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN)