BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T25 STARDRIVE SHAFT F/MATRIX STANDARD

    MDR report key: 3041343 · Received April 8, 2013

    Report

    Report Number
    1719045-2013-10545
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    June 30, 2011
    Report Date
    June 30, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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. 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. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. MANUFACTURING EVALUATION REVEALED THAT THE RETURNED DEVICE THAT THE STARDRIVE SHAFT WAS RETURNED WITH THE TIP DAMAGED. ALL OF THE LOBE EDGES ARE ROUNDED; TWO LOBES HAVE MATERIAL BROKEN AWAY FROM THE TIP, TWO HAVE MATERIAL DISPLACED BEYOND THE TIP, AND TWO WERE DENTED. THERE IS A DEEP DENT AROUND THE PERIMETER OF THE STARDRIVE FORM. THE SHAFT HAS SCRATCHES INDICATING USE. THE MEASURABLE DIMENSIONS ARE WITHIN PRINT SPECIFICATION. THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT BECAUSE THE DAMAGED PORTION OF THE PRODUCT MAKES PHYSICAL DIMENSIONAL VERIFICATION IMPOSSIBLE. BASED ON THE CONDITION OF THE DEVICE AND THE EVALUATION, THE COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURER STANDPOINT. PRODUCT DEVELOPMENT EVALUATION REVEALED THAT THE VISUAL EXAMINATION OF THE INSTRUMENT DID NOT SHOW ANY ISSUES. THERE IS NO EVIDENCE OF A STRIPPED DRIVER. THERE IS A VERY SMALL AMOUNT OF DEFORMATION ON THE TIPS OF FOUR STARDRIVE LOBES. THE DESCRIPTION OF A STRIPPED CAP DRIVER WAS NOT EVIDENT ON THE RETURNED DEVICE. THERE IS A VERY SMALL AMOUNT OF DEFORMATION ON THE TIPS OF THE FOUR STARDRIVE LOBES THAT IS CONSISTENT WITH NORMAL USE OF THE DEVICE AND WOULD NOT BE A CONTRIBUTOR TO A STRIPPED CONDITION. THE STARDRIVE SHAFT WAS EVALUATED USING THE TORQUE LIMITING HANDLE 03.620.061 THAT WAS ALSO RETURNED WITH THIS COMPLAINT. THE SHAFT/HANDLE COMBINATION WAS ABLE TO DELIVER THE CORRECT AMOUNT OF TORQUE TO TIGHTEN A MATRIX LOCKING CAP. THE SAME SHAFT/HANDLE COMBINATION WAS ALSO ABLE TO LOOSEN A MATRIX LOCKING CAP WITHOUT ISSUE. A SECOND EVALUATION WAS PERFORMED USING THE STARDRIVE SHAFT FROM THIS COMPLAINT AND A DIGITAL TORQUE METER. THE STARTDRIVE SHAFT WAS ABLE TO DELIVER 12NM OF LOCKING TORQUE TO THE LOCKING CAP AND APPEARED TO BE FUNCTIONING AS INTENDED. TWELVE NM IS THE MAXIMUM AMOUNT OF TORQUE THAT THE TORQUE LIMITING HANDLE CAN PROVIDE SO THE STARDRIVE SHAFT SHOULD NEVER SEE A TORQUE IN EXCESS OF THIS AMOUNT. THE DEVICE APPEARS TO BE FUNCTIONING AS INTENDED AND DOES NOT SEEM TO BE A CONTRIBUTOR TO THE STUCK LOCKING CAP. BASED ON THE CONDITION OF THE DEVICE AND THE EVALUATION, THE COMPLAINT IS DEEMED INVALID.

    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. ORIGINAL AWARENESS DATE IS (B)(4) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PLACEMENT OF HARDWARE FOR A LUMBAR DECOMPRESSION AND FUSION AT L4-S1, SURGEON DECIDED TO REPOSITION A SCREW AFTER REVIEWING THE X-RAYS. THE LOCKING CAP GOT STUCK IN THE LEFT L4 PEDICLE SCREW. SURGEON USED REMOVAL TECHNIQUE AND CAP DRIVERS BECAME STRIPPED. TWO T25 STARDRIVE SHAFTS AND THE TORQUE LIMITING RATCHET HANDLE STRIPPED DURING LOCKING CAP REMOVAL AT LEFT L4, SURGEON REMOVED AND REPLACED TWO LOCKING CAPS HOWEVER, ONE LOCKING CAP AND SCREW COULD NOT BE REMOVED AND REMAIN IN THE PATIENT. ON THE RIGHT SIDE, THREE LOCKING CAPS WERE REMOVED AND REPLACED. SURGEON REPLACED L5 SCREW WITH ANOTHER SCREW AND CAP TO COMPLETE PROCEDURE. THE PROCEDURE COMPLETED, BUT WAS PROLONGED FORTY-FIVE MINUTES. THIS IS REPORT 6 OF 7 FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 6 OF 7 FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144091 T25 STARDRIVE SHAFT F/MATRIX STANDARD HXX SYNTHES MONUMENT 6495447

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention