BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RATCHET T-HANDLE 6MM QC

    MDR report key: 3031831 · Received April 2, 2013

    Report

    Report Number
    1719045-2013-10503
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    May 16, 2012
    Report Date
    May 16, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 THAT THE PARTS WERE TESTED FOR FUNCTION AS RECEIVED AND THE UNIT FAILED; THE HANDLE SLIPPED WHEN USED IN THE FORWARD AND REVERSE POSITIONS, WHEN FORCE WAS APPLIED. THERE WAS NO HISTORY ON THE DEVICE TO INDICATE USAGE, TIMES AUTOCLAVED, OR CLEANING CYCLES. IT IS BELIEVED THAT THIS COULD BE A SERVICE ISSUE SINCE IT IS RECOMMENDED THAT PARTS BE ON A RECALIBRATION/REVIEW CYCLE. PARTS WERE REVIEWED AND MET DIMENSIONAL SPECIFICATIONS AND WERE MANUFACTURED AND PROCESSED PER THE SPECIFICATION REQUIREMENTS. THIS COMPLAINT CONDITION IS NOT RELATED TO THE MANUFACTURING PROCESS. PRODUCT DEVELOPMENT EVALUATION REVEALED NO FUNCTIONAL OR DESIGN ABNORMALITIES WITH RESPECT TO DRIVER ASSEMBLY OR RATCHETING FUNCTION. THE RATCHETING T-HANDLE WAS PRESENTED AS RECEIVED, ACCOMPANIED BY A LONG T25 DRIVER. THE T-HANDLE WAS COUPLE/DECOUPLE WITH THE T25 DRIVER, AND SUCCESSFULLY PERFORM EACH OF THE RATCHETING FUNCTIONS (CLOCK-WISE RATCHETING, NEUTRAL POSITIONING, & COUNTER CLOCK-WISE RATCHETING) WITHOUT INCIDENT. NO REVIEW OF THE COMPLAINT HISTORY WAS PERFORMED, AS THE DEVICE SHOWED NO EVIDENCE OF DEFICIENCY. THE MATRIX SURGICAL TECHNIQUE GUIDES, ILLUSTRATE THE PROPER METHOD OF LOADING & UNLOADING MATRIX PEDICLE SCREWS USING A LOCKING HOLDING SLEEVE IN CONJUNCTION WITH A MATRIX T25 DRIVER. EVIDENCE WOULD INDICATE THAT THE ISSUE WAS CAUSED BY UNFAMILIARITY WITH INSTRUMENT FUNCTION. DUE TO THE LACK OF EVIDENCE REGARDING DEFICIENT PERFORMANCE, THIS COMPLAINT IS CONSIDERED INVALID FROM A MANUFACTURING PERSPECTIVE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    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. NO, THIS DEVICE WAS NOT RETURNED TO MANUFACTURE AS PREVIOUSLY REPORTED. THERE WAS A MIX UP WITH THE PART TRACKERS. THE PRODUCT ASSOCIATED WITH THIS MDR WAS NEVER RECEIVED. THE MFG EVALUATION AND PD EVALUATION WAS PREVIOUSLY INCORRECTLY REPORTED AND HAS NOW BEEN CORRECTLY REPORTED IN (B)(4). ORIGINAL AWARENESS DATE IS 05/16/2012. NO, DEVICE WAS NOT RETURNED TO MANUFACTURER. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. HOWEVER, AS THE PRODUCT WAS NOT RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE L4-S1 LUMBAR FUSION THE MATRIX SCREW TECHNIQUE WAS FOLLOWED TO FINAL TIGHTEN THE SCREWS. THE SURGEON PROCEEDED TO ADJUST THE ROD ON THE PATIENT'S RIGHT SIDE. THE LOCKING CAP AT L5 WOULD NOT LOOSEN WITH THE STRAIGHT HANDLE SCREWDRIVER. NEXT THE T-HANDLE SCREWDRIVER AND COUNTER-TORQUE WERE USED; THIS ALSO WOULD NOT LOOSEN THE SCREW. THE SURGEON ATTEMPTED TO LOOSEN THE LOCKING CAP WITH THE TECHNIQUE DESCRIBED IN THE MATRIX TECHNIQUE GUIDE WITH THE TORQUE HANDLE AND COUNTER TORQUE, THE SURGEON WAS UNSUCCESSFUL. THE TECHNIQUE WITH THE SIMPLE PERSUADER WAS THEN USED ALONG WITH RATCHET T-HANDLE AND STRAIGHT TIP DRIVER AT WHICH THE RATCHET DRIVER FAILED UNDER THE FORCE APPLIED. A NEW HANDLE WAS THEN PUT ON THE STRAIGHT TIP DRIVER AND THE SURGEON TRIED AGAIN. THE STRAIGHT TIP SCREWDRIVER BROKE NEAR THE TIP UNDER THE HIGH FORCE WHICH WAS APPLIED. TWO SMALL PIECES OF SCREWDRIVER TIP WERE RETRIEVED AND APPEARED TO BE ALL ACCOUNTED FOR. THE PATIENT WAS UNHARMED. THE SURGEON THEN DECIDED TO FORGO FURTHER ATTEMPTS TO LOOSEN THE LOCKING CAP. THIS IS 8 OF 10 REPORTS FOR THE SAME EVENT.

    Description of Event or Problem · 1

    (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133888 RATCHET T-HANDLE 6MM QC HXX SYNTHES MONUMENT 6599437

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR