BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/MED

    MDR report key: 5995576 · Received October 3, 2016

    Report

    Report Number
    1719045-2016-10731
    Event Type
    Malfunction
    Date Received
    October 3, 2016
    Date of Event
    September 26, 2016
    Report Date
    September 26, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE SUBJECT DEVICE WAS RECEIVED. THE INVESTIGATION HAS NOT BEEN COMPLETED, AND NO HAS CONCLUSION HAS BEEN DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER U102248. MANUFACTURING LOCATION: (B)(4). DATE OF MANUFACTURE: FEB 13, 2009. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. CORRECTED DATA: THE CORRECT LOT NUMBER OF THE SUBJECT DEVICE WAS PROVIDED TO THE MANUFACTURER ON OCT 11, 2016. 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

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. NO PATIENT INFORMATION HAS BEEN PROVIDED. UDI#: (B)(4) UNKNOWN LOT NUMBER (POSSIBLY U182248). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE CURRENT MANUFACTURE IS NOTED AS ORCHID UNIQUE, WHICH IS A SUPPLIER. INVALID LOT AND ITEM NUMBER COMBINATION, POSSIBLE LOT NUMBER APPEARS TO BE U182248. 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

    A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICES. FOUR (4) MATRIXNEURO SCREWDRIVER BLADES, HEX COUPLING/SELF-RETAINED/MEDIUM [PART NUMBER 03.503.017 / LOT NUMBER U159987 (QTY. 2) AND LOT NUMBER U102248 (QTY. 2)] WERE RECEIVED WITH THE COMPLAINT CATEGORY OF ¿DOES NOT/WILL NOT FUNCTION : WILL NOT HOLD.¿ IT WAS REPORTED THAT DURING A PROCEDURE FOUR (4) SCREWDRIVER BLADES WERE USED AND FOUND TO NOT HOLD THE SCREW PROPERLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER SAME/LIKE PRODUCT. THERE WAS NO SURGICAL DELAY REPORTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE COMPLAINT CONDITION IS CONFIRMED AS THE WEAR OBSERVED ON THE DISTAL TIP OF EACH SCREWDRIVER WOULD LEAD TO THE SCREWDRIVERS NOT RETAINING A SCREW AS TIGHTLY AS INTENDED. A DEVICE HISTORY RECORD (DHR) REVIEW, VISUAL INSPECTION, FUNCTIONAL TEST, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED AND THE RISK ASSESSMENT WAS FOUND TO ADEQUATELY ADDRESS THE COMPLAINT CONDITION. PART FAMILY 03.503.01X COMES IN TWO LENGTHS [03.503.016 (SHORT) AND 03.503.017 (MEDIUM)] AND IS PART OF THE MATRIXNEURO SYSTEM. THESE SCREWDRIVERS ARE INTENDED RETAIN THE SCREW WITHOUT A HOLDING SLEEVE DURING USE. THIS INFORMATION IS PROVIDED PER THE NEXT GENERATION CRANIAL PLATING SYSTEM: MATRIXNEURO TECHNIQUE GUIDE. THE SCREWDRIVERS WERE RECEIVED INTACT WITH LIGHT WEAR. ON EACH SCREWDRIVER THE PROXIMAL COUPLING HEX AND THE DISTAL CRUCIFORM BLADE SHOW SLIGHTLY WORN EDGES. DUE TO THE WEAR OF EACH DISTAL TIP THE SCREWDRIVERS WOULD NOT RETAIN A SCREW AS TIGHTLY AS INTENDED. THUS, THE COMPLAINT CONDITION IS CONFIRMED AND CONSISTENT WITH THE REPORTED CONDITION. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE MATING SCREW WAS NOT RETURNED. A REVIEW OF THE CURRENT DESIGN DRAWING / MANUFACTURED REVISION WAS PERFORMED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED GIVEN THE UNKNOWN USE AT THE TIME OF THE ISSUE AND OVER THE LIFETIME OF EACH DEVICE. THE CONDITION APPEARS CONSISTENT WITH THE RESULT OF ABRASION OF DRIVER FROM SIGNIFICANT REPETITIVE USE. INFORMATION ON CARE AND MAINTENANCE IS PROVIDED PER THE PROCESSING SYNTHES REUSABLE MEDICAL DEVICES ¿ INSTRUMENTS, INSTRUMENT TRAYS, AND CASES. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2016, A CRANIOTOMY WAS PERFORMED ON A PATIENT. DURING THE PROCEDURE, FOUR (4) SCREWDRIVER BLADES WERE USED AND FOUND TO NOT HOLD THE SCREW PROPERLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER SAME/LIKE PRODUCT; THERE WAS NO SURGICAL DELAY REPORTED. THE REPORTER STATED THAT EVERYTHING WAS OK WITH THE PATIENT AND THAT THERE WAS NO HARM REPORTED. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646207 MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/MED SCREWDRIVERS HXX SYNTHES MONUMENT U102248

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANT