BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RATCHETING SCREWDRIVER HANDLE

    MDR report key: 7855257 · Received September 7, 2018

    Report

    Report Number
    2939274-2018-53661
    Event Type
    Malfunction
    Date Received
    September 7, 2018
    Report Date
    August 16, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10887587035673
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 311.023, LOT# T945853. MANUFACTURING LOCATION: (B)(4), RELEASE TO WAREHOUSE DATES: (B)(6) 2010 AND (B)(6) 2010. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS INITIALLY EVALUATED AT SERVICE AND REPAIR. THE REPAIR TECHNICIAN REPORTED THE SWITCH WAS DAMAGED AND NOT MOVING UP AND DOWN, AND THE HANDLE HAD WEAR MARKS ON THE FRONT. DAMAGED COMPONENT IS THE REASON FOR REPAIR. THE ITEM WAS DEEMED NOT REPAIRABLE PER THE INSPECTION SHEET AND FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. THE HANDLE WAS RECEIVED INTACT WITH SCRAPING OBSERVED AT THE PROXIMAL END OF THE TOGGLE SWITCH ON THE HANDLE. NO BREAKS OR FRACTURES WERE OBSERVED. THE BALANCE OF THE DEVICE SHOWS SURFACE WEAR CONSISTENT WITH USE AND WHICH WOULD NOT IMPACT THE FUNCTIONALITY. THE DEVICE HAS A TOGGLE SWITCH ON THE HANDLE THAT ALLOWS THE DEVICE TO BE PLACED IN ONE OF THREE POSITIONS; CLOCKWISE RATCHETING, NEUTRAL, AND COUNTERCLOCKWISE RATCHETING. DURING FUNCTIONAL TESTING IT WAS IDENTIFIED THAT THE SWITCH WAS STUCK IN THE NEUTRAL POSITION AND COULD NOT BE ADVANCED OR RETRACTED. NO OTHER FUNCTIONAL ISSUES WERE OBSERVED. IT WAS DETERMINED THAT THE RECEIVED CONDITION DOES AGREE WITH THE COMPLAINT DESCRIPTION AND CAN BE REPLICATED BUT DIFFERS SLIGHTLY IN THAT THE HANDLE IS NOT BROKEN INTO PIECES BUT IS NON-FUNCTIONAL DUE TO THE SEIZED TOGGLE SWITCH. 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 IS NOT APPLICABLE FOR THIS CONDITION AS THE ISSUE IS RELATED TO SEIZING OF THE INTERNAL COMPONENTS. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS PROBABLE THAT THE ISSUE IS THE RESULT OF INTERNAL DAMAGE AND THAT AGE OF THE DEVICE (OVER 8 YEARS OLD) AND ANY UNINTENDED FORCES ENCOUNTERED BY THE DEVICE DURING USAGE COULD HAVE CONTRIBUTED SEIZED CONDITION. THE COMPLAINT CONDITION IS CONFIRMED AS THE HANDLE WAS RECEIVED WITH THE TOGGLE SWITCH STUCK IN THE NEUTRAL POSITION. REVIEW OF THE DEVICE HISTORY RECORD OF TUTTLINGEN SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE THAT WOULD CONTRIBUTE TO THE ISSUE OUTLINED IN THIS COMPLAINT. 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.

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. DATE OF EVENT IS UNKNOWN. ADDITIONAL PROCODE: LXH. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. REPORTER EMAIL ADDRESS IS UNAVAILABLE. REPORTER IS A SYNTHES SALES CONSULTANT. 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 DURING TESTING ON AN UNKNOWN DATE, THE RATCHETING SCREWDRIVER HANDLE WAS NOT WORKING ON THE DEVICE. IT WAS DETERMINED THAT THE RATCHETING SCREWDRIVER HANDLE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE: TRAUMA DEVICE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A RATCHETING SCREWDRIVER HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698432 RATCHETING SCREWDRIVER HANDLE SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 311.023 T945853 10887587035673

    Patients

    Seq Age Sex Outcome Treatment
    1 THERAPY DATE: UNKNOWN