BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM CANCELLOUS BONE SCREW PARTIALLY THREADED/35MM

    MDR report key: 3093445 · Received May 6, 2013

    Report

    Report Number
    2520274-2013-02355
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    SYTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED AND THE REPORT INDICATES THE RETURNED SMALL HEXAGONAL SCREWDRIVER LONG WAS MANUFACTURED IN DECEMBER 2010 AND IS OVER 2 YEARS OLD. THE SHAFT COMPONENT WAS MANUFACTURED FROM 440A SS WHICH IS A TYPICAL MATERIAL USED TO MAKE HEXAGONAL SCREWDRIVER SHAFTS. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RETURNED SCREW WAS MANUFACTURED FROM 316L IMPLANT GRADE SS WHICH IS A TYPICAL MATERIAL USED TO MAKE IMPLANT SCREWS. THE LOW PROFILE PELVIC PLATE SYSTEM RISK ANALYSIS ADEQUATELY ASSESSES THE RISK ASSOCIATED WITH THIS COMPLAINT CONDITION. THE SCREW WAS RETURNED WITH FRACTURED THREADED TIP, THE TIP FRAGMENT WAS NOT RETURNED FOR EVALUATION. THE SCREW SHAFT IS BENT AND THE SCREW HEAD IS NO LONGER PERPENDICULAR THE SHAFT. THE BENT SCREW INFERS THAT AN OFF AXIS FORCE WAS APPLIED DURING INSERTION CAUSING THE SCREW TO BEND AND BREAK AND ULTIMATELY CAUSING THE SCREWDRIVER TIP TO BREAK. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Description of Event or Problem · 1

    THE SALES CONSULTANT REPORTED AN ISSUE WITH THE SCREWDRIVER THAT OCCURRED DURING OPEN REDUCTION INTERNAL FIXATION SURGERY (ORIF) OF TIBIA. THE SCREWDRIVER BROKE OFF IN THE HEAD OF THE SCREW ON (B)(6) 2013. CONCURRENTLY, THE HEAD OF THE SCREW AND APPROXIMATELY 1/2 OF THE SCREW SHAFT ALSO BROKE OFF DURING SURGERY. THE BALANCE OF THE SCREW SHAFT REMAINS IMPLANTED. THE SURGEON COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEM. THE TIP OF THE DRIVER WAS DISCARDED BY THE FACILITY. THIS IS 1 OF 2 DEVICES FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS IS 1 OF 2 DEVICES FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196460 4.0MM CANCELLOUS BONE SCREW PARTIALLY THREADED/35MM HWC SYTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR