BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAFT FOR 90° SCREWDRIVER

    MDR report key: 6038828 · Received October 19, 2016

    Report

    Report Number
    3000270450-2016-10248
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    September 26, 2016
    Report Date
    September 27, 2016
    Manufacturer
    SYNTHES SELZACH
    Product Code
    DZI
    PMA / PMN Number
    K082649
    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. ADDITIONAL NARRATIVE: ADDITIONAL PRODUCT CODE: DZJ. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: 26. APRIL 2013. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICES (SHAFTS FOR 90° SCREWDRIVER, PART NUMBER 03.505.003, LOT NUMBERS 8100827 AND 8130113). THE RETURNED SUBJECT DEVICES ARE USED ALONG WITH 90° SCREWDRIVERS WHICH OFFER A TOOL WHICH CAN BE USED TO PERFORM MINIMALLY INVASIVE PREDRILLING AND INSERTION OF SCREWS WITHOUT ADDITIONAL INCISIONS. THE 90° SCREWDRIVER CAN BE FOUND IN THE MATRIXRIB TECHNIQUE GUIDE. BOTH SHAFTS WERE RETURNED WITH MINOR SUPERFICIAL MARKS INDICATIVE OF ROUTINE USE. ONE OF THE RETURNED SHAFTS (LOT NUMBER 8100827) WAS RECEIVED WITH ITS INNER SHAFT WHICH HAS THE DRIVE/TORQUE MECHANISM ATTACHED TO IT HAVING A DIFFERENT LOT NUMBER (8130113) ETCHED ON IT. IT IS POSSIBLE THAT THE TWO SEPARABLE PARTS WHICH COMPOSE THE SHAFT FOR 90° SCREWDRIVER WAS DISASSEMBLED DURING STERILIZATION AND REASSEMBLED WITH COMPONENTS WITHOUT MATCHING LOT NUMBERS. THE OUTER BODIES WHICH HOUSE THE INNER SHAFT/DRIVE MECHANISM DIDN'T CONTRIBUTE TO THE COMPLAINT CONDITION, HOWEVER, IT WAS DISCOVERED THAT ONE OF THE TWO INNER SHAFTS (8130113) WERE MISSING THE BALL BEARINGS WHICH ALLOW THE DRIVE MECHANISM TO FUNCTION AS INTENDED. SINCE THE COMPLAINT CONDITION WAS ONLY CONFIRMED FOR ONE OF THE TWO RETURNED SHAFTS, AS THE COMPLAINT WAS UNABLE TO BE REPLICATED WITH THE OTHER SHAFT NO FURTHER INVESTIGATION INCLUDING A DRAWING REVIEW, ROOT CAUSE ANALYSIS, AND RISK ASSESSMENT IS NECESSARY FOR THAT RETURNED PART. THEREFORE THE COMPLAINT CONDITION IS CONFIRMED FOR ONE OF THE RETURNED SHAFTS BUT NOT FOR THE OTHER. AS PART OF THIS INVESTIGATION A VISUAL INSPECTION, DRAWING REVIEW, ROOT CAUSE ANALYSIS, AND RISK MANAGEMENT ASSESSMENT WERE PERFORMED. THE RETURNED SHAFT WITH THE CONFIRMED COMPLAINT CONDITION WAS MANUFACTURED ON 26APR13 AND DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY WHEN USED AND HANDLED AS RECOMMENDED. NO MRRS, NCRS, OR ACTIONS RELATED TO THE COMPLAINT CONDITION WERE GENERATED DURING PRODUCTION OF THE RETURNED PART(S). REVIEW OF DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT(S) WHICH WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON THE AVAILABLE INFORMATION IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE COMPLAINT CONDITION. ACCORDING TO THE 90° SCREWDRIVER¿S INSTRUCTION FOR DISASSEMBLY, CLEANING, AND MAINTENANCE DOCUMENT, USERS ARE INSTRUCTED TO DISASSEMBLE THE DEVICE PRIOR TO STERILIZATION. IT IS POSSIBLE THAT ROUGH HANDLING DURING STERILIZATION AND/OR DURING A PROCEDURE MIGHT HAVE CONTRIBUTED TO THE DAMAGE TO THE BALL BEARINGS, WHICH CAUSED THEM TO FALL OUT AND IN TURN DAMAGED THE DRIVE MECHANISM WHICH CAUSED THE COMPLAINT CONDITION. 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 ON AN EVENT IN (B)(6) AS FOLLOWS: (B)(6) REPORTED THAT TWO SCREWDRIVER SHAFTS WERE BROKEN. NO FURTHER INFORMATION WAS PROVIDED. IT WAS NOTED THAT THE TWO SCREWDRIVER SHAFTS REPORTEDLY HAD SOME VIBRATION DURING THE PROCEDURE. THERE WERE OTHER INSTRUMENTS AVAILABLE TO USE TO COMPLETE THE PROCEDURE. NO FRAGMENTS WERE GENERATED, AND NO REPORTED PATIENT HARM. THERE ARE TWO DEVICES ON THIS COMPLAINT. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693532 SHAFT FOR 90° SCREWDRIVER DRILL, BONE, POWERED DZI SYNTHES SELZACH 8130113

    Patients

    Seq Age Sex Outcome Treatment
    1