BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S4 ROD-TO-ROD CONNECTOR REVIS.SCREW DRV.

    MDR report key: 5091301 · Received September 21, 2015

    Report

    Report Number
    3005673311-2015-00130
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Report Date
    March 16, 2016
    Manufacturer
    AESCULAP AG
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: RECEIVED FOR EVALUATION: (B)(4) / S4 CLOSED/OPEN DOMINO CONNECTOR 7MM (LOT NUMBER 51966436). TWO (B)(4) / S4 CLOSED/OPEN DOMINO CONNECTOR 11MM (LOT NUMBERS 52032386 / 5192607). (B)(4) / S4 PARALLEL ROD CONNECTOR. (B)(4) / S4 REVISION SCREWDRIVER. (B)(4) / SET SCREW. TWO RODS; REFERENCE AND LOT NUMBER UNKNOWN. THE (B)(4) AND THE (B)(4) (S4 DOMINO CONNECTORS) WERE MEASURED WITH THE RESULTS THAT THE DEVICES ARE TRUE TO GAUGE. NO DIMENSION DEVIATION COULD BE DETERMINED. ALL DEVICES WERE INVESTIGATED MICROSCOPICALLY. AS MENTIONED IN THE COMPLAINT REPORT THE SET SCREW (B)(4) WAS TIGHTENED WITH EXCESSIVE FORCE WHICH RESULTED IN THE (B)(4) REVISION SCREWDRIVER DAMAGING THE SET SCREW AND BECOMING STUCK IN THE HEXAGON OF THE SCREW. THE OUTER THREAD OF THE SET SCREW ((B)(4)) AND THE INNER THREAD OF THE DOMINO CONNECTOR ((B)(4)) DISPLAY VISUAL DAMAGE AS A RESULT OF THE HIGH FORCE USED. THE ROD CONNECTORS WERE TESTED FOR STATIC AND DYNAMIC LOADING. WITH CORRECT APPLICATION IT IS POSSIBLE TO GET A SUFFICIENT STABILITY FOR THE CONSTRUCT. THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL AVAILABLE LOT NUMBERS. THE DEVICE HISTORY FILE HAS BEEN CHECKED AND FIND TO BE ACCORDING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THESE BATCHES. BASED ON THE INFORMATION AVAILABLE AS WELL AS THE RESULTS OF THE INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS USER RELATED. IT IS POSSIBLE THE RODS WERE NOT IN THE EXACT POSITION FOR AN ADEQUATE SUFFICIENTLY FIXATION. THEREFORE IT WAS NOT ABLE TO FIX THE CONSTRUCT IN THE EXPECTED STABILITY. A PRODUCT OR DESIGN FAILURE WAS EXCLUDED. NO CORRECTIVE ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). MEDICAL TREATMENT A FEW YEARS AGO WITH S4 FROM L1 TO L4. GOOD BONE STRUCTURE AND FUSION UP TO NOW. NEW FRACTURE OF VERTEBRAL BODY AT TH12. SCHEDULED INDICATION: EXTENSION OF EXISTING L1-L4 TREATMENT FROM L4 TO TH9 AMONGST OTHERS WITH DOMINO CONNECTORS. (3X SW346T, 2X SW344T, 1X SW366T, 2X SW842T, 1X SW841T, 1X SW821T). SURGEON TRIED TO FIX THE CONNECTOR WITH TORQUE DRIVER FW207R, BUT COULDN'T TIGHTENED THE SCREW, SO THAT THE NEW CONSTRUCTION FEELS VERY INSTABLE. THE CONSTRUCT WAS NOT STABLE AGAINST ROTATION. FURTHER ATTEMPTS WERE MADE WITH ANOTHER SCREW DRIVER, FW491R WITHOUT SUCCESS; ALTHOUGH USING BRUTE FORCE. AS A CONSEQUENCE THE SCREW DRIVER STUCK IN ONE CONNECTOR (SW841T) SO THAT THE SCREW DRIVER COULD NOT BE LOOSENED FROM THE CONNECTOR. SURGEON WAS NOT HAPPY WITH THE CONSTRUCT AND HE DECIDED TO CHANGE THE TOTAL CONSTRUCT (INCLUSIVE OF THE FORMER L1-L4 MEDICAL TREATMENT). AN ADDITIONAL CUT OF APPROX. 20CM WAS NECESSARY. PATIENT IS FINE NOW, BUT THE SURGERY WAS EXTENDED ABOUT 1 1/2 HOUR. ADDITIONAL COMPONENTS RETURNED FOR EVALUATION: 2X SW843T / S4 CLOSED/OPEN DOMINO CONNECTOR 11MM. 1X SW841T / S4 CLOSED/OPEN DOMINO CONNECTOR 7MM. 1X SW821T (AND FRAGMENTS OF PINS) / S4 PARALLEL ROD CONNECTOR D5.5/5.5MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622373 S4 ROD-TO-ROD CONNECTOR REVIS.SCREW DRV. SCREW DRIVER HXX AESCULAP AG FW491R

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other