BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE-LONG FOR MATRIX

    MDR report key: 3961886 · Received July 28, 2014

    Report

    Report Number
    1719045-2014-10339
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 30, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 WAS COMPLETED: (B)(6) MANUFACTURED THE HOLDING SLEEVE-LONG FOR MATRIX, PART NUMBER 03.632.036, LOT NUMBER 6746390. THE CERTIFICATE OF COMPLIANCE INDICATED THE LOT CONFORMED TO SPECIFICATIONS. THE HOLDING SLEEVE WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET. THERE WERE NO MATERIAL REVIEW REPORTS, NON-CONFORMANCE REPORTS, OR COMPLAINT-RELATED ISSUES WITH THIS LOT. 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

    (B)(4): A MANUFACTURING EVALUATION WAS COMPLETED: THE INVESTIGATION OF THE COMPLAINED TWO RETAINING SLEEVE SHOWS THAT A PART OF PITCH THE THREAD BROKE OFF. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE. REVIEW OF DOCUMENTATION FOR PRODUCTION AND MATERIAL SHOWS CONFORMITY. IT IS LIKELY THAT A SHORT MECHANICAL OVERLOAD CAUSED THIS DAMAGE DURING SCREW INSERTION. THESE FORCES CAN BE THE RESULT OF, AS FOR EXAMPLE, STRONG SOFT TISSUE PUSH OR EXCESSIVE CORRECTION OF THE SCREW TRAJECTORY. THESE FORCES MAY OVERSTRESS THE MATERIAL WITH SUBSEQUENT FAILURE OF THE TIP OF THE RETAINING SLEEVE. ALTERNATIVELY THE CONNECTION BETWEEN RETAINER CARTRIDGE AND BONE SCREW COULD BE ACCIDENTALLY PARTIALLY DETACHED BY HOLDING THE GREEN KNOB WITHIN SCREWING. SYNTHES PROVIDES WITH THE LOCKABLE RETAINER CARTRIDGE (03.616.043) AN ALTERNATIVE INSTRUMENT WHICH CAN BE HOLD ON THE KNOB BY SCREWING. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE THREAD FROM THE RETAINING SLEEVE SHEARED OFF WHEN TRYING TO PICK UP THE SCREW. THIS HAPPENED WITH TWO DEVICES. SUBSTITUTE INSTRUMENTS WERE USED. THIS IS REPORT 2 OF 2 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437600 HOLDING SLEEVE-LONG FOR MATRIX MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT 6746390

    Patients

    Seq Age Sex Outcome Treatment
    1