BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE-LONG FOR MATRIX

    MDR report key: 3735288 · Received April 9, 2014

    Report

    Report Number
    1719045-2014-10130
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Report Date
    March 18, 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: THE INVESTIGATION OF THE COMPLAINED INSTRUMENT SHOWS A BREAKAGE OF A PART OF THE FIRST THREAD AT THE THREAD TIP. IT IS LIKELY THAT THE INSTRUMENT WAS NOT IN THE PRIME LOCK THREAD OF THE BONE SCREW ENOUGH AND THAT COULD BE THE POSSIBLE CAUSE OF THIS DAMAGE. OR IT IS POSSIBLE THAT THERE WAS AN UNINTENDED PARTIALLY DISSOLVING WITH THE HOLDING OF THE GREEN KNOB IN THE PROCEDURE OF INSERTING THE CONNECTION BETWEEN THE HOLDING SLEEVE AND BONE SCREW. THE LOCKING RETAINING SLEEVE (03.616.043) IS AN ALTERNATIVE INSTRUMENT, WHICH CAN BE HOLD DURING THE INSERTING PROCEDURE. THE CONDUCTED INVESTIGATION OF THE MANUFACTURING AND MATERIAL DOCUMENTS SHOWS NO DEVIATION ACCORDING OUR SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. 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 DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE AVALIGN TECHNOLOGIES - NEMCOMED MANUFACTURED THE HOLDING SLEEVE-LONG FOR MATRIX, P/N 03.632.036, LOT NUMBER 6860569 PER PO # 1348317, DATED APRIL 17, 2012, FOR 174 PARTS. THE C OF C DATED APRIL 13, 2012, INDICATED THE LOT CONFORMED TO SPECIFICATIONS. THE HOLDING SLEEVE WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER NS035211 REVISION ¿P¿. 174 PARTS WERE RELEASED TO THE WAREHOUSE ON APRIL 18, 2012. THERE WERE NO MRRS, NCRS, OR COMPLAINT-RELATED ISSUES WITH THIS LOT. THE HOLDING SLEEVE-LONG FOR MATRIX WAS MADE TO THE SYNTHES TABULATED DRAWING NUMBER 03.632.001, REVISION ¿J¿, RELEASED ON JULY 12, 2011, WHICH INCLUDED P/N 03.632.036. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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: THE COMPLAINT RECEIVED STATES THAT THE THREAD AT THE DISTAL TIP IS BROKEN. THERE WAS NO PATIENT HARM REPORTED. NO ADDITIONAL INFORMATION ABOUT THE EVENT IS AVAILABLE AT THIS TIME. DEVICE WILL BE RETURNED FOR INVESTIGATION. THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213944 HOLDING SLEEVE-LONG FOR MATRIX MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT 6860569

    Patients

    Seq Age Sex Outcome Treatment
    1