BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM

    MDR report key: 7847838 · Received September 5, 2018

    Report

    Report Number
    2939274-2018-53635
    Event Type
    Malfunction
    Date Received
    September 5, 2018
    Report Date
    August 20, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982068934
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED. PART: 03.010.472 , LOT: 7840007 , MANUFACTURING SITE: HAEGENDORF , RELEASE TO WAREHOUSE DATE: 22.MAR.2012 . THE DEVICE HISTORY RECORD SHOWS THIS LOT OF (B)(4) PIECES 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. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. SERVICE AND REPAIR EVALUATION: THE DEVICE WAS INITIALLY RETURNED AT SERVICE AND REPAIR AND THE REPAIR TECHNICIAN EVALUATION ON THE DEVICE IS AS BELOW: THE CUSTOMER REPORTED THE TIP OF THE SCREWDRIVER WAS PARTIALLY STRIPPED. THE REPAIR TECHNICIAN REPORTED THE TIP WAS DAMAGED AND THE INSTRUMENT WAS MISSING THE NUT AND SLIDER. TIP BROKEN 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: DEVICE CONDITION: UPON VISUAL INSPECTION ON THE RETURNED DEVICE AT CUSTOMER QUALITY A SLIGHTLY DEFORMED TIP WAS NOTED. FURTHERMORE, THE SLIDER BAR AND THE NUT COMPONENT WERE NOT RETURNED AND WERE REPORTED MISSING. NO FURTHER ISSUES SUCH AS TIP BREAKAGE WERE IDENTIFIED ON THE DEVICE DURING VISUAL INSPECTION UNDER 5X MAGNIFICATION AT US CUSTOMER QUALITY. THE RECEIVED DEVICE CONDITION AGREE WITH THE COMPLAINT DESCRIPTION AND THE COMPLAINT WAS CONFIRMED. DIMENSIONAL ANALYSIS AND DOCUMENT/SPECIFICATION REVIEW: RELEVANT DRAWINGS FOR THE DEVICE WERE REVIEWED AND NO DESIGN ISSUES WERE NOTED. DIMENSIONAL INSPECTION WAS NOT POSSIBLE ON THE RELEVANT PORTIONS DUE TO POST MANUFACTURE DEFORMATION AND MISSING COMPONENTS CONDITIONS. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED HOWEVER, IT IS LIKELY THAT THE DEVICE EXPERIENCED EXCESSIVE FORCE DURING SCREW INSERTION OR DURING HANDLING. CONCLUSION: THE OVERALL COMPLAINT CONDITION WAS CONFIRMED; HOWEVER, NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES WERE IDENTIFIED DURING 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.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN WHEN DEVICE BECAME STRIPPED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. REPORTER EMAIL ADDRESS IS UNKNOWN. 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 REVIEW 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

    IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN INSPECTION OF RECEIVED INSTRUMENTS, IT WAS NOTICED THAT THE TIP OF INTER-LOCKED SCREWDRIVER APPEARS PARTLY STRIPPED. IT WAS ALSO NOTED THAT PARTS WERE MISSING. THE MISSING PARTS ARE THE SLIDER AND THE NUT FOR THE SLIDE. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT. THIS REPORT IS FOR AN INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686161 INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7840007 10886982068934

    Patients

    Seq Age Sex Outcome Treatment
    1