BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE-LONG FOR MATRIX

    MDR report key: 3063739 · Received April 17, 2013

    Report

    Report Number
    1719045-2013-10726
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    September 29, 2011
    Report Date
    September 29, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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. THE PRODUCT DEVELOPMENT EVENT EVALUATION REVEALED THAT THE THREADS OF THE RETAINING SLEEVES WERE INSPECTED UNDER MAGNIFICATION. THE THREADS SHOWED SOME MINOR WEAR, BUT THIS IS NOT INCONSISTENT WITH NORMAL USE. DESPITE THE WEAR THE SLEEVES STILL FUNCTIONED AS INTENDED WHEN ASSEMBLED WITH A DRIVER SHAFT AND AN UNDAMAGED SCREW. THE SCREW WAS RETAINED AS INTENDED AND EACH SLEEVE, ALONG WITH A DRIVER, WAS CAPABLE OF INSERTING A BONE SCREW INTO THE PEDICLE OF A BONE MODEL WITHOUT INCIDENT. BOTH SLEEVES FUNCTIONED AS INTENDED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. MAGNUM MANUFACTURING CENTER MANUFACTURED THE HOLDING SLEEVE. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. (B)(4).

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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.THE AMOUNT OF HOLDING SLEEVES WAS NOT PREVIOUSLY LISTED ON THE PREVIOUS MEDWATCHES.NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN L5-S1 TLIF PROCEDURE, THE SURGEON WAS FINAL TIGHTENING AND THE TEETH CHIPPED OFF THE DRIVER THAT WAS BEING USED. ALSO, THE SCRUB TECHNICIAN CROSS THREADED THE HOLDING SLEEVE. THE RECOIL MECHANISM IN THE PERSUADER MALFUNCTIONED, AND PERSUADER HAD TO BE PRIED OPEN, THE LOCKING MECHANISM IN THE FLEX ARM MALFUNCTIONED AND WOULD NOT RELEASE. THE RETRACTOR RATCHETING MECHANISM STRIPPED. ALL OF THESE INSTRUMENTS ARE FROM EVALUATION SETS. THE DRIVER, HOLDING SLEEVE AND PERSUADER ARE FROM EVALUATION SET 95877370. THE FLEX ARM AND RETRACTOR ARE FROM EVALUATION SET 96039793. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    THIS IS 1 OF 2 REPORT FOR 2 HOLDING SLEEVES IN COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165712 HOLDING SLEEVE-LONG FOR MATRIX LXH SYNTHES MONUMENT 6602185

    Patients

    Seq Age Sex Outcome Treatment
    1