BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTRACTOR TIP FOR MATRIX DETACHABLE HOLDING SLEEVE

    MDR report key: 3070716 · Received April 22, 2013

    Report

    Report Number
    1719045-2013-10719
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. MANUFACTURING EVALUATION REPORTS THE PART WAS RECEIVED WITH THE INNER THREAD DAMAGED. AXIAL SCRATCHES LOCATED ON THE SHAFT ARE INDICATIVE OF USAGE. DUE TO THE DAMAGE AT THE TIP INNER DIAMETER MEASURED UNDERSIZED. OTHER MEASURABLE DIMENSIONS WERE IN PRINT SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. PRODUCT DEVELOPMENT EVENT EVALUATION REVEALS, THE DEVICE WAS ASSEMBLED WITH A DETACHABLE HOLDING SLEEVE AND A DRIVER SHAFT WITHOUT ISSUE. THE ASSEMBLE INSTRUMENTS WERE MATED TO A MATRIX BONE SCREW AND WERE INSERTED INTO A LUMBER BONE MODEL WITHOUT ISSUE. THE DEVICE RELEASED FROM THE SLEEVE AND SCREW AS INTENDED. DESPITE THE SLIGHT DAMAGE TO THE TIP THE DEVICE PERFORMED AS DESIGNED. THE DAMAGE APPEARED TO BE THE RESULT OF CROSS THREADING TO THE BONE SCREW, THE SLIGHT DEFECT DID NOT AFFECT INSTRUMENT PERFORMANCE. THIS COMPLAINT IS CONSIDERED INDETERMINATE.

    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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE AT L4-L5, THE THREADS BEGAN TO PEEL OFF A SCREW, WHILE WITH THE DISTRACTOR TIP. THERE WERE NO LOOSE FRAGMENTS FROM THE THREADED TIP. THE SURGEON USED ANOTHER SET OF DEVICES TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170981 DISTRACTOR TIP FOR MATRIX DETACHABLE HOLDING SLEEVE LXH SYNTHES MONUMENT 6280687

    Patients

    Seq Age Sex Outcome Treatment
    1