BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RATCHETING SCREWDRIVER HANDLE

    MDR report key: 6365358 · Received February 28, 2017

    Report

    Report Number
    9680938-2017-10028
    Event Type
    Malfunction
    Date Received
    February 28, 2017
    Report Date
    January 19, 2017
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HXX
    UDI-DI
    10887587035673
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON PART # 311.023 / LOT # A70A23: IN TOTAL THERE WERE 5 DIFFERENT MANUFACTURING LOTS UNDER THIS LOT # A7OA23: BA# 901907- MANUFACTURING DATE: 09-JUN-2005 (32 PARTS); BA# 901908- MANUFACTURING DATE: 10-JUN-2005 (32 PARTS); BA# 901909- MANUFACTURING DATE: 10-JUN-2005 (31 PARTS); BA# 901910- MANUFACTURING DATE: 10-JUN-2005 (32 PARTS); BA# 901407- MANUFACTURING DATE: 10-JUN-2005(38 PARTS). REVIEW OF THE DEVICE HISTORY RECORD OF (B)(4) SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE THAT WOULD CONTRIBUTE TO THE ISSUE OUTLINED IN THIS COMPLAINT. A REVIEW OF INSPECTION RECORDS AND CERTIFICATIONS, CONFIRM THAT THE COMPONENTS AND FINAL PRODUCT MET INSPECTION RECORDS. ALL PARTS OF THE LOT WERE CHECKED 100% FOR IMPORTANT FEATURES AND FOR FUNCTION WITH A SPECIAL GAGE AT THE FINAL INSPECTION. NO NON CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED. ONE (1) RATCHETING SCREWDRIVER HANDLE (PART # 311.023, LOT # A7OA23) WAS RECEIVED. THE COMPLAINT CONDITION IS CONFIRMED. THE HANDLE WAS RECEIVED WITH A PIECE OF THE HANDLE COMPONENT AND A PRONG FROM THE END CAP COMPONENT BROKEN OFF. THE BROKEN PORTION OF THE HANDLE WAS RECEIVED. THE BROKEN PRONG FROM THE END CAP WAS NOT RECEIVED. A DEVICE HISTORY RECORD (DHR) REVIEW, VISUAL INSPECTION, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE HANDLE WAS RECEIVED A PROXIMAL PIECE OF THE HANDLE COMPONENT BROKEN OFF FROM THE BODY. THE BROKEN PORTION WAS RECEIVED AND MEASURES APPROX. 13.6MM BY 17.7MM AT ITS LONGEST AND WIDEST, RESPECTIVELY. ADDITIONALLY, THE END CAP HAS A BROKEN PRONG WHICH WAS NOT RETURNED. DUE TO THE MISSING PRONG THE END CAP CANNOT BE SECURED INTO THE BODY. THE BALANCE OF THE DEVICE SHOWS SURFACE WEAR CONSISTENT WITH USE AND IS IN FUNCTIONAL CONDITION. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE DEVICE IS ALREADY BROKEN. THE RETURNED SCREWDRIVER HANDLE (311.023) IS INTENDED FOR USE ACROSS VARIOUS PLATING SYSTEMS IN TRAUMA AND CMF PROCEDURES. THE 2.4MM LCP DISTAL RADIUS SYSTEM TECHNIQUE GUIDE WAS REVIEWED. THE SCREWDRIVER HANDLE ALLOWS FOR SCREW INSERTION/REMOVAL WITH THE OPTION TO HAVE THE RATCHETING MECHANISM TURNED ON OR OFF. RELEVANT DRAWINGS WERE REVIEWED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR ITS INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. AS THE CIRCUMSTANCES AT THE TIME OF THE ISSUE AND OVER THE LIFESPANS OF THE DEVICES ARE UNKNOWN A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. THE RETURNED CONDITION OF THE SCREWDRIVER HANDLE IS CONSISTENT WITH THE HANDLE BEING EXPOSED TO EXCEEDING FORCES RESULTING IN SEPARATION OF THE PROXIMAL PORTION OF THE CYLINDRICAL HANDLE AND THE END CAP. THESE FORCES WOULD NOT BE EXPECTED FROM RECOMMENDED USE. 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 STERILE PROCESSING FOUND A RATCHETING SCREWDRIVER HANDLE AND DEPTH GAUGE DAMAGED. REPORTER WAS NOT GIVEN DETAILS TO WHAT KIND OF DAMAGE THE PRODUCT HAS. IT IS UNKNOWN IF EITHER PRODUCT WAS USED IN A SURGERY. DURING MANUFACTURER PRELIMINARY INVESTIGATION PROCESS IT WAS IDENTIFIED THAT A PIECE OF THE RETURNED RATCHETING SCREWDRIVER HANDLE WAS BROKEN OFF FROM THE BODY. ADDITIONALLY, THE END CAP IS MISSING A PRONG AND WILL NOT SECURE INTO THE BODY. THIS MISSING PRONG WAS NOT RETURNED. ALSO THE NEEDLE OF THE DEPTH GAUGE WAS DETACHED FROM THE BODY. NO PIECES WERE FOUND TO BE MISSING. THESE CONDITIONS WERE RE-EVALUATED AND DETERMINED TO BE REPORTABLE ON FEB 3, 2017. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148413 RATCHETING SCREWDRIVER HANDLE SCREWDRIVERS HXX SYNTHES TUTTLINGEN A7OA23 10887587035673

    Patients

    Seq Age Sex Outcome Treatment
    1