BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM SCREWDRIVER SELF-RETAINING

    MDR report key: 7468562 · Received April 27, 2018

    Report

    Report Number
    2939274-2018-51944
    Event Type
    Injury
    Date Received
    April 27, 2018
    Date of Event
    April 9, 2018
    Report Date
    April 9, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10887587037028
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. PATIENT ID: 541240 PART 313.925, LOT 4223406: RELEASE TO WAREHOUSE DATE: JANUARY 19, 2001. MANUFACTURED BY SYNTHES BRANDYWINE. NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS COMPLETED: THE RETURNED SCREWDRIVER WAS INSPECTED AND THE COMPLAINT WAS CONFIRMED. VISUAL INSPECTION OBSERVED ABOUT HALF PORTION OF THE SCREW DRIVER TIP WAS BROKEN. BROKEN FRAGMENTS WERE NOT RETURNED AT CUSTOMER QUALITY. NO SIGNS OF DAMAGE WERE OBSERVED ON REMAINING PORTIONS OF THE DEVICE. THE RECEIVED CONDITION AGREE WITH THE COMPLAINT DESCRIPTION AND THE COMPLAINT WAS CONFIRMED. RELEVANT DRAWINGS FOR THE RETURNED DEVICE WERE REVIEWED. BOTH DIMENSIONAL ANALYSIS AND A MATERIAL CHECK OR HARDNESS CHECK WERE NOT PERFORMED AS THERE IS NO INDICATION THAT THE MATERIAL OR HARDNESS AND DEVICE SPECIFICATIONS WOULD HAVE CONTRIBUTED TO THE COMPLAINT CONDITION FOR THIS 17+ YEAR OLD REUSABLE INSTRUMENT. ADDITIONALLY, DEVICE SHOWS POST MANUFACTURING DAMAGE SUCH THAT A RELEVANT DIMENSIONAL CHECK COULD NOT BE PERFORMED. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS LIKELY THAT CONSISTENT USE OF DEVICE FOR OVER 17 YEARS AND ANY UNINTENDED EXCESSIVE FORCE ENCOUNTERED BY THE DEVICE DURING ITS USE AND HANDLING WITH COULD HAVE LED TO THIS BROKEN COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES OR 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.

    Additional Manufacturer Narrative · 1

    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. A DEVICE HISTORY RECORD REVIEW WAS REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 · 1

    THE SUBJECT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER AND IS UNDERGOING INVESTIGATION. THE RESULTS OF THE INVESTIGATION ARE PENDING COMPLETION AND WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. 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 THE TIP OF A SCREWDRIVER BROKE WHILE PLACING A SCREW IN THE PATIENT¿S MANDIBLE DURING A PROCEDURE ON (B)(6) 2018. THE WOUND WAS EXAMINED AND A PIECE OF THE DRIVER WAS RECOVERED. IT IS UNKNOWN IF ALL THE PIECES OF THE DRIVER WERE REMOVED. THE WOUND WAS COPIOUSLY IRRIGATED AND SUCTIONED. THIS BREAKAGE ADDED 15 MINUTES TO THE CASE. NO PATIENT CONSEQUENCE REPORTED. NO OTHER ADDITIONAL INFORMATION AVAILABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312405 2.4MM SCREWDRIVER SELF-RETAINING SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 313.925 4223406 10887587037028

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention