BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7808751 · Received August 23, 2018

    Report

    Report Number
    2939274-2018-53439
    Event Type
    Malfunction
    Date Received
    August 23, 2018
    Date of Event
    June 26, 2018
    Report Date
    June 26, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982068941
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. PART: 03.010.473; LOT: 9171664; MANUFACTURING SITE: (B)(4); RELEASE TO WAREHOUSE DATE: FEBRUARY 24, 2015. THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND FUNCTIONAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS INITIALLY RETURNED TO SERVICE AND REPAIR AND THE SERVICE AND REPAIR TECHNICIAN EVALUATED THE DEVICE AS NOTED BELOW: THE CUSTOMER REPORTED THE TIP OF THE SCREWDRIVER WAS NICKED. THE REPAIR TECHNICIAN REPORTED THE DEVICE WAS RETURNED IN PIECES, AND THE TIP OF THE SCREWDRIVER WAS 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. CUSTOMER QUALITY INVESTIGATION: INVESTIGATION FLOW: DAMAGE: VISUAL (APPEARANCE NOT AS EXPECTED) VISUAL INSPECTION: THE SCREWDRIVER WAS RECEIVED AT CQ WITH SHAFT AND SLIDING BAR NOT BEING INTACT. THE DISTAL TIP OF THE MAIN BODY SHOWS PARTIAL AXIAL TWISTING IN THE DIRECTION OF RESISTANCE FROM SCREW INSERTION. THE SLIDING BAR COMPONENT SHOWS SLIGHT DEFORMATION OF A DISTAL CORNER OF THE DISTAL TIP BUT DOES NOT SHOW TWISTING OR MATCHING DEFORMATION WITH THE MAIN BODY. THE BALANCE OF THE DEVICE SHOWS SURFACE WEAR CONSISTENT WITH USE AND WHICH WOULD NOT IMPACT THE FUNCTIONALITY. IT WAS DETERMINED THAT THE RECEIVED CONDITION DOES AGREE WITH THE COMPLAINT DESCRIPTION AS THE DEVICE IS TWISTED AND DEFORMED. DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION, WERE REVIEWED. RELEASE TO WAREHOUSE DATE: FEBRUARY 24, 2015 SD25/3.5MM HEX SCREWDRIVER, INTER-LOCK, SHAFT (COMPONENT), SLIDING BAR (COMPONENT). DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DIMENSIONAL INSPECTION: DUE TO THE DAMAGE, ACCURATE DIMENSIONAL INSPECTION OF THE DISTAL DRIVE FEATURE COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED AS CIRCUMSTANCES SURROUNDING THE EVENT ARE UNKNOWN. HOWEVER, THE CONDITION OF THE SLIDING BAR SHOWS EVIDENCE THAT THE SLIDING BAR WAS NOT FULLY ADVANCED WHEN THE DEFORMATION OCCURRED. PER THE TECHNIQUE GUIDE, THE SLIDING BAR IS TO BE ¿FULLY WEDGED INTO THE SCREW HEAD RECESS.¿ CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED AS THE DISTAL TIP OF THE MAIN SCREWDRIVER SHAFT IS TWISTED. THE SLIDING BAR SHOWS SLIGHT DEFORMATION OF THE DISTAL EDGE BUT DOES NOT SHOW MATCHING DEFORMATION WITH THE MAIN BODY. THE CONDITION OF THE SLIDING BAR SHOWS EVIDENCE THAT THE SLIDING BAR WAS NOT FULLY ADVANCED WHEN THE DEFORMATION OCCURRED. NO DESIGN OR MANUFACTURING DEFECT OR DEFICIENCY WAS OBSERVED DURING THE INVESTIGATION. NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. 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 · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, THE TIP OF AN INTER-LOCK SCREWDRIVER, T25 STAR DRIVE WAS NICKED. IT IS THOUGHT THAT THE NICK OCCURRED WHEN THE SURGEON WAS TRYING TO RETRIEVE A SCREW IN BONE UNDER X-RAY, AND THE SCREW CAUSED A NICK WHEN TRYING TO LOCK ON THE SCREWDRIVER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED. NO PATIENT OUTCOME REPORTED. THIS REPORT IS FOR AN INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651583 INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9171664 10886982068941

    Patients

    Seq Age Sex Outcome Treatment
    1