BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/MED

    MDR report key: 6368307 · Received March 1, 2017

    Report

    Report Number
    1719045-2017-10158
    Event Type
    Malfunction
    Date Received
    March 1, 2017
    Report Date
    February 6, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    UDI-DI
    10887587011554
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INVOLVEMENT REPORTED. DATE OF EVENT IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 03.503.017, LOT# U102248. SUPPLIER: (B)(6), RELEASE TO WAREHOUSE DATE: (B)(6) 2009. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. 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 RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. A VISUAL INSPECTION UNDER 5X MAGNIFICATION, FUNCTIONAL TEST, DEVICE HISTORY RECORD (DHR) REVIEW AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THIS COMPLAINT IS CONFIRMED. THE RETURNED SCREWDRIVER HANDLE WITH HEX COUPLING-MEDIUM (PART#311.006, LOT#T929536) INTERMITTENTLY RETAINED THE RETURNED SCREWDRIVER SHAFTS. THE COMPLAINT CONDITION WAS ABLE TO BE REPLICATED AT CUSTOMER QUALITY (CQ). THE CAUSE FOR THIS COMPLAINT IS THE KNURLED SLEEVE COMPONENT ON THE SCREWDRIVER HANDLE WITH HEX COUPLING GETTING STUCK ON THE PLASTIC BEARING AND NOT ALLOWING THE KNURLED SLEEVE TO TRAVEL CONSISTENTLY DISTALLY IN ORDER TO RETAIN THE MATING SCREWDRIVER SHAFTS. SLIGHT PRESSURE/FORCE IS REQUIRED TO MOVE THE KNURLED SLEEVE DISTALLY OFF THE BEARING AND THEN IT RETAINS THE MATING SCREWDRIVER SHAFTS AS INTENDED. FEATURES RELEVANT TO THIS COMPLAINT (PLASTIC BEARING MAX OUTSIDE DIAMETER AND KNURLED SLEEVE INSIDE DIAMETER AT PROXIMAL END) COULD NOT BE MEASURED AT CQ BECAUSE THEY ARE NOT ACCESSIBLE IN THIS 8 YEAR OLD DEVICE'S ASSEMBLED CONDITION. REGARDING THE (3) MATRIX NEURO SCREWDRIVERS NO LONGER HAVE THEIR SELF-RETAINING CAPABILITY; THIS WAS NOT ABLE TO BE CONFIRMED OR REPLICATED AT CQ. THE DISTAL TIPS SHOWED NO DAMAGE THAT WOULD PREVENT FUNCTION AND NO MATING SCREWS WERE RETURNED IN ORDER TO ATTEMPT REPLICATION OF THE COMPLAINT CONDITION. RELEVANT DRAWINGS WERE REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THE ROOT CAUSE COULD BE BIO BURDEN TRAPPED INTERNALLY CAUSING THE KNURLED SLEEVE TO HANG UP ON THE BEARING FOR THIS 8+YEAR OLD REUSABLE INSTRUMENT. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. 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 BY THE SALES CONSULTANT THAT DURING INSPECTION OF HIS FIELD EQUIPMENT THE FOLLOWING DEVICE MALFUNCTIONS WERE NOTED: ONE (1) SCREW DRIVER HANDLE IS TOUGH TO PULL BACK, AND IT DOESN'T SNAP FORWARD WHEN THE SCREW DRIVER BLADE IS INSERTED. THREE (3) MATRIX NEURO SCREWDRIVERS NO LONGER HAVE THEIR SELF-RETAINING CAPABILITY. THIS COMPLAINT IS NOT ASSOCIATED WITH A PROCEDURE OR PATIENT. THIS REPORT IS FOR ONE (1) MATRIX NEURO SCREWDRIVER BLADE. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152169 MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/MED SCREWDRIVERS HXX SYNTHES MONUMENT U102248 10887587011554

    Patients

    Seq Age Sex Outcome Treatment
    1