BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM

    MDR report key: 7435560 · Received April 17, 2018

    Report

    Report Number
    2939274-2018-51728
    Event Type
    Malfunction
    Date Received
    April 17, 2018
    Date of Event
    March 24, 2018
    Report Date
    March 26, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982068941
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DATE REPORTED IN INITIAL REPORT WAS 4/3/2018. CORRECT DATE SHOULD HAVE BEEN 3/26/2018 DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DHR REVIEW WAS COMPLETED PART NO.: 03.010.473 , LOT NO.: 9171772 , MANUFACTURING LOCATION: HAEGENDORF , RELEASE TO WAREHOUSE DATE: 26.MAY.2015 . NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. CUSTOMER QUALITY CONDUCTED AN INVESTIGATION OF THE RETURNED DEVICE. SERVICE & REPAIR EVALUATION THE CUSTOMER REPORTED THE SCREWDRIVER WAS BROKEN. THE REPAIR TECHNICIAN REPORTED THE TIP OF THE SCREWDRIVER AND THE ATTACHMENT WERE BENT. BENT IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. THIS COMPLAINT IS CONFIRMED FOR POST MANUFACTURING DAMAGE. HOWEVER, THE DEVICE IS NOT BROKEN. THE RETURNED DEVICE WAS VISUALLY INSPECTED AT CUSTOMER QUALITY AND THE DISTAL TIP OF THE MAIN DRIVER SHAFT WAS OBSERVED TO BE SIGNIFICANTLY TWISTED IN THE DIRECTION OF RESISTANCE ENCOUNTERED DURING SCREW INSERTION. THE DISTAL TIP OF THE SLIDER BAR SHAFT IS NOT TWISTED AT ALL WHICH INDICATES THAT BOTH TIPS WERE NOT SEATED IN THE SCREW HEAD RECESS WHEN TORQUE WAS APPLIED RESULTING IN THE MAIN DRIVER TIP TWISTING. ONE DISTAL CORNER/EDGE OF THE SLIDER BAR SHAFT IS MALFORMED/BENT BUT NOT TWISTED. THE NUT COMPONENT WAS RETURNED WITH NO DAMAGE. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) VIA FUNCTIONAL TEST IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION. THE RETURNED DEIVCE WAS MANUFACTURED IN MAY 2015 AND IS APPROXIMATELY 3 YEARS OLD. A DEVICE HISTORY REVIEW, INCLUDING MATERIAL AND HARDNESS REVIEWS, WAS PERFORMED FOR THE RETURNED INSTRUMENT¿S LOT NUMBER AND NO NCRS, MRRS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ALSO, BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT ANY ISSUES WITH MATERIAL OR MATERIAL PROPERTIES CONTRIBUTED TO THE COMPLAINT CONDITION. RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED (BOTH FROM THE TIME OF MANUFACTURE AND PRESENT REVISION): TOP-LEVEL, MAIN SHAFT COMPONENT, AND SLIDING BAR COMPONENT,AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN AND APPLICATION WHEN USED AS RECOMMENDED. THE 03.010.473 INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM IS INTENDED FOR INSERTION AND REMOVAL OF DISTAL LOCKING SCREWS DURING FEMORAL AND TIBIAL NAIL PROCEDURES. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. AN ACCURATE DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED AT CQ FOR THE RETURNED MAIN DRIVER SHAFT COMPONENT DUE TO THE TWISTED CONDITION. THE OVERALL LENGTH OF THE RETURNED SLIDER BAR COMPONENT MEASURED 106.09MM AT CQ WHICH IS WITHIN SPECIFICATION OF 106.0MM +/-0.5MM PER SLIDING BAR COMPONENT DRAWING WHICH CONFIRMS THAT NO BREAKAGE OCCURRED. BECAUSE THE DISTAL TIP OF THE SLIDER BAR SHAFT IS NOT TWISTED AT ALL, THIS SUGGESTS THAT BOTH TIPS WERE NOT SEATED IN THE SCREW HEAD RECESS WHEN TORQUE WAS APPLIED RESULTING IN THE MAIN DRIVER TIP TWISTING. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS ALSO POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES SUCH AS EXCESSIVE TWISTING DURING USAGE COULD HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE FOR A TIBIAL NAILING ON (B)(6) 2018. THE SURGEON COMPLETED THE PROCEDURE AND DECIDED TO ENSURE THAT THE 4.0MM LOCKING SCREW WAS TIGHT BY USING A SCREWDRIVER THAT LOCKS TO THE SCREW. AN INTER-LOCK SCREWDRIVER WAS USED TO SUCCESSFULLY TIGHTEN THE SCREW. WHEN THE SURGEON REMOVED THE SCREWDRIVER, IT WAS NOTED THAT THE TIP OF THE SCREWDRIVER HAD BECOME BENT/WARPED. THERE WAS NO BREAKAGE OR FRAGMENTS. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS NOTED AS STABLE. CONCOMITANT DEVICE REPORTED: 4.0MM TITANIUM LOCKING SCREW WITH T25 STARDRIVER 38MM FOR IM NAILS (04.005.428S, LOT NUMBER UNKNOWN, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER IS A COMPANY REPRESENTATIVE; NO FACILITY PHONE NUMBER IS AVAILABLE THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SCREW DRIVER WAS BROKEN INTRA-OPERATIVELY ON AN UNKNOWN DATE IN AN UNKNOWN PROCEDURE. THERE WAS NO DELAY IN PROCEDURE AND NO PATIENT HARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279262 INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9171772 10886982068941

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR