BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETAIN-SLEEVE LONG F/MATRIX 5.5

    MDR report key: 3152137 · Received June 7, 2013

    Report

    Report Number
    1719045-2013-01533
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 13, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS (B)(6). INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT 6860569 REVEALED THE HOLDING SLEEVE-LONG FOR MATRIX WAS MANUFACTURED BY AVALIGN-NEMCOMED, (B)(4), DATED 4/17/12, FOR (B)(4) PARTS, WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER (B)(4) ON 4/18/12. THE PRODUCT CONFORMED TO ALL REQUIREMENTS. THE CERTIFICATE OF COMPLIANCE IS DATED 4/13/12. (B)(4) PARTS WERE RELEASED TO THE WAREHOUSE ON 4/18/12. DUE TO AN UNKNOWN CAUSE, THE THREADED TIP BROKE. THE MATERIAL OF THE INNER SLEEVE WAS CONFIRMED TO BE WITHIN SPECIFICATION AS WELL AS THE MAJOR DIAMETER OF THE THREADS. THE THREADED TIP DEPTH AND LOCATION WERE UNABLE TO BE VERIFIED DUE TO THE DAMAGE ON THE TIP. THE PARTS ALL PASSED INSPECTION AT THE TIME OF MANUFACTURING.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED: FIRST THREAD FLANK BROKE OFF DURING SURGERY. THE PIECE WAS BROKEN WHEN TRYING TO CATCH THE IMPLANT SCREW. THE SURGERY LASTED LONGER THAN DESIRED, BUT THE PATIENT DID NOT SUFFER ANY SEQUELAE. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252494 RETAIN-SLEEVE LONG F/MATRIX 5.5 LXH SYNTHES MONUMENT 6860569

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR