BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE FOR 90° SCREWDRIVER

    MDR report key: 7843288 · Received September 4, 2018

    Report

    Report Number
    2939274-2018-53598
    Event Type
    Malfunction
    Date Received
    September 4, 2018
    Report Date
    July 3, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    1088758701330
    PMA / PMN Number
    K082649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO KNOWN REPORTED PATIENT INVOLVEMENT ASSOCIATED WITH THE COMPLAINED EVENT. ADDITIONAL DEVICE PRODUCT CODES: DZJ, DZI. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR PART: 03.505.004, LOT: 8064583: MANUFACTURING SITE: (B)(4), SUPPLIER: (B)(4): RELEASE TO WAREHOUSE DATE: 17. APRIL 2007: THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 100 PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL 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. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE HANDLE WAS RECEIVED WITH AN UNKNOWN METAL CYLINDRICAL OBJECT (PIN/WIRE/ROD) STUCK IN THE PROXIMAL CANNULATION. THE UNKNOWN METAL OBJECT COULD NOT BE REMOVED AND WOULD NOT BE INTENDED TO BE PRESENT. THE BALANCE OF THE DEVICE SHOWS SURFACE WEAR CONSISTENT WITH USE AND WHICH WOULD NOT IMPACT THE FUNCTIONALITY. FUNCTIONAL TEST: THE HANDLE WAS ASSEMBLED WITH THE RETURNED MATING PARTS, PART 03.505.005 / LOT 8161905 AND PART 03.505.003 / LOT 8064582. IT WAS NOTED THAT ONE OF THE TWO RETURNED SHAFTS (PART 03.505.003 / LOT 8062742) WAS MISSING THE INNER SHAFT; THUS, THIS DEVICE WAS NOT USED FOR THE FUNCTIONAL TESTING. DURING ASSEMBLY IT WAS OBSERVED THAT THE DISTAL KNOB WOULD NOT SIT FLUSH WITH THE HANDLE DUE TO THE UNKNOWN METAL OBJECT IN THE PROXIMAL CANNULATION. THE KNOB WOULD STILL ROTATE BUT COULD NOT BE FULLY ASSEMBLED ON THE PROXIMAL END OF THE HANDLE. THE DISTAL CONNECTION TO THE MATING SHAFT WAS FOUND TO ASSEMBLE AND DISASSEMBLE AND FUNCTION. IT WAS DETERMINED THAT THE RECEIVED CONDITION DOES AGREE WITH THE COMPLAINT DESCRIPTION AND CAN BE REPLICATED WITH THE RETURNED DEVICES AS THE DISTAL KNOB WOULD NOT SIT FLUSH WITH THE HANDLE DUE TO THE UNKNOWN METAL OBJECT IN THE PROXIMAL CANNULATION. DOCUMENT/SPECIFICATION REVIEW: THE RELEVANT DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION, WERE REVIEWED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DIMENSIONAL INSPECTION: THE INNER CANNULATION OF THE HANDLE COULD NOT BE INSPECTED DUE TO THE STUCK FOREIGN OBJECT. ADDITIONALLY, DURING USE, A CYLINDRICAL OBJECT SUCH AS THE OBJECT OBSERVED, WOULD NOT BE EXPECTED TO BE INSERTED IN THE CANNULATION. CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED AS, DURING ASSEMBLY, THE MATING DISTAL KNOB WOULD NOT SIT FLUSH WITH THE HANDLE DUE TO THE UNKNOWN METAL OBJECT IN THE PROXIMAL CANNULATION. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED AS CIRCUMSTANCES SURROUNDING THE EVENT ARE UNKNOWN. HOWEVER, GIVEN THAT A CYLINDRICAL OBJECT SUCH AS THE OBJECT OBSERVED, WOULD NOT BE EXPECTED TO BE INSERTED IN THE CANNULATION, THE CONDITION CAN BE ATTRIBUTED TO DEVICE USE. NO DESIGN OR MANUFACTURING DEFECT OR DEFICIENCY WAS OBSERVED DURING THE 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 INSPECTION ON (B)(6) 2018, IT WAS NOTED THAT THERE WERE ISSUES WITH THE HANDLE FOR A NINETY (90) DEGREES SCREWDRIVERS, TURNING HANDLES FOR THE SCREWDRIVERS, AND THE SHAFTS FOR THE NINETY (90) DEGREES SCREWDRIVERS DID NOT FIT CORRECTLY. THIS COMPLAINT DOES NOT INVOLVE A PATIENT OR A PROCEDURE. THIS REPORT IS FOR ONE (1) HANDLE FOR 90° SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683462 HANDLE FOR 90° SCREWDRIVER SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 8064583 1088758701330

    Patients

    Seq Age Sex Outcome Treatment
    1