BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING

    MDR report key: 7747499 · Received August 3, 2018

    Report

    Report Number
    2939274-2018-53177
    Event Type
    Malfunction
    Date Received
    August 3, 2018
    Report Date
    July 18, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982067975
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE 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. PART: 03.010.150; SYNTHES LOT: 5791434; SUPPLIER LOT: N/A; RELEASE TO WAREHOUSE DATE: MAY 28, 2008; EXPIRATION DATE: N/A; SUPPLIER: ; MANUFACTURED BY SYNTHES BRANDYWINE; NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INSTRUMENT WAS RECEIVED WITH THE REPORTED CONDITION OF ¿VISUAL FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION: RM¿ THE FOLLOWING INVESTIGATION FLOW WAS PERFORMED: VISUAL (APPEARANCE NOT AS EXPECTED): THE RETURNED INSTRUMENT WAS EXAMINED AND THERE IS NO EVIDENCE OF BROWN STAIN COMING OUT OF THE HANDLE. THE BALANCE OF THE DEVICE IS IN WORN CONDITION. THE RECEIVED CONDITION DOES NOT AGREE WITH THE COMPLAINT DESCRIPTION. A DEVICE HISTORY REVIEW, WAS PERFORMED FOR THE RETURNED INSTRUMENT¿S LOT NUMBER AND NO MATERIAL REVIEW REPORTS (MRRS), NCRS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. RELEVANT DRAWINGS FOR THE RETURNED DEVICE WERE REVIEWED (BOTH CURRENT AND FROM THE TIME OF MANUFACTURE): TOP-LEVEL DRAWING, HANDLE COMPONENT DRAWING AND SHAFT COMPONENT DRAWING WERE REVIEWED, AND NO ISSUES WERE IDENTIFIED. A DIMENSIONAL INSPECTION WAS NOT PERFORMED AS THE COMPLAINT IS RELATED TO FOREIGN SUBSTANCE AND NOT ANY RELEVANT FEATURE ON THE INSTRUMENT. THERE IS NO VISUAL EVIDENCE OR TANGIBLE EVIDENCE ON THE RETURNED INSTRUMENT THAT CONFIRMS THE REPORTED CONDITION. A DEFINITIVE ROOT CAUSE FOR THE REPORTED COMPLAINT CONDITION COULD NOT BE DETERMINED BECAUSE THE COMPLAINT COULD NOT BE CONFIRMED. IT IS POSSIBLE THAT THE SPECIFIC STERILIZATION PROCEDURE AT THE REPORTING HOSPITAL HAS CONTRIBUTED TO THE REPORTED EVENT AND SUBSEQUENT DECONTAMINATION OF THE DEVICE AT SYNTHES MONUMENT SITE HAS REMOVED ALL EVIDENCE OF THE REPORTED CONDITION. HOWEVER, THIS CANNOT BE DEFINITIVELY CONFIRMED. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES 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

    ADDITIONAL NARRATIVE: THERE IS NO PATIENT INVOLVEMENT. DATE OF EVENT IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A DEVICE HISTORY RECORD HAS BEEN REQUESTED. 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

    (B)(4) REPORTS THAT AFTER STERILIZATION ON AN UNKNOWN DATE, THE HANDLES FOR (6) HEXAGONAL SCREWDRIVERS LEAVE A BLACK STAIN ON THE WHITE PEEL PACK. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR A STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING. THIS IS REPORT 1 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588305 STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5791434 10886982067975

    Patients

    Seq Age Sex Outcome Treatment
    1