BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETAIN-SLEEVE LONG F/MATRIX 5.5

    MDR report key: 3083382 · Received April 29, 2013

    Report

    Report Number
    1719045-2013-10810
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    October 5, 2011
    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

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RECEIVED FOR A MANUFACTURING EVALUATION AND THE FIRST THREAD WAS BROKEN OFF AT THE MINOR DIAMETER. THERE WERE AXIAL SCRATCHES ON THE SHAFT INDICATING USE. THE GREEN ANODIZE HAS BEEN SLIGHTLY REMOVED FROM THE EDGES OF THE KNOB, WHICH GENERALLY INDICATES USE. THE DIMENSIONS MEASURED WERE WITHIN PRINT SPECIFICATION. THIS COMPLAINT IS INVALID FROM A MANUFACTURING STANDPOINT. A PRODUCT DEVELOPMENT EVALUATION WAS ALSO PERFORMED. OTHER THAN ONE FULL THREAD BEING BROKEN OFF THE DISTAL TIP, THERE WAS NO VISIBLE DAMAGE OR DEFORMITY TO THE INSTRUMENT. THE DEVICE FUNCTIONED INDEPENDENTLY AS INTENDED. THE FAILURE MECHANISM DISPLAYED BY THE DAMAGED INSTRUMENT COULD ONLY BE ACHIEVED THROUGH AN APPLIED TENSILE LOAD. THE CONDITION OF THE HOLDING SLEEVE THREADS INDICATES THAT WHILE ENGAGING THE IMPLANT INTERFACE, A CANTILEVER LOAD WAS APPLIED TO ASSEMBLY CAUSING A LOAD CONCENTRATION ON THE INITIAL SECTION OF THE IDENTIFIED THREADS WHICH EXCEEDED THE DESIGN TENSILE LIMITS. NO OTHER EVIDENCE OF DAMAGE WAS OBSERVED. THE MATRIX TECHNIQUE GUIDE, AS WELL AS OTHER PRODUCT SUPPORT INFORMATION, FULLY ILLUSTRATES THE PROPER METHOD OF LOADING AND UNLOADING SCREWS FROM A HOLDING SLEEVE. EVIDENCE INDICATES AN IMPROPERLY AGGRESSIVE SURGEON TECHNIQUE EXCEEDING THE DESIGN INTENDED LIMITS WAS THE CAUSE OF FAILURE. HOWEVER, THE IMPLANT WAS NOT RETURNED, SO THE COMPLAINT MUST BE RENDERED INDETERMINATE FROM A DESIGN STANDPOINT. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIRST TURN OF THE RETAIN-SLEEVE THREAD BROKE OFF INTRAOPERATIVELY AS THEY TRIED TO RECONNECT THE RETAINING SLEEVE WITH THE PEDICLE SCREW. THIS REPORT IS FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183575 RETAIN-SLEEVE LONG F/MATRIX 5.5 LXH SYNTHES MONUMENT 6583190

    Patients

    Seq Age Sex Outcome Treatment
    1