BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM

    MDR report key: 6198655 · Received December 22, 2016

    Report

    Report Number
    3003875359-2016-10661
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    November 30, 2016
    Report Date
    November 30, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HXX
    UDI-DI
    10886982069641
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT DOB & WEIGHT NOT PROVIDED FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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: PART 03.019.025 LOT 8993496. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 03 OCTOBER 2014. NO NCR'S WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SCREWDRIVER (PART NUMBER 03.019.025, LOT NUMBER 8993496). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING THE KNOB IS CONFIRMED TO BE BROKEN FROM THE INNER SHAFT OF THE SCREWDRIVER. THE REMAINDER OF THE DEVICE IS IN GOOD CONDITION WITH NO OTHER ISSUES NOTED. A VISUAL INSPECTION, DRAWING REVIEW AND DEVICE HISTORY RECORD (DHR) REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT IS CONFIRMED. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE DEVICE IS ALREADY BROKEN. NO NON-CONFORMANCE RECORDS (NCR'S) WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. DRAWINGS WERE REVIEWED DURING INVESTIGATION. THE DESIGN HISTORY WAS NOT FOUND TO IMPACT THE COMPLAINT CONDITION. 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 THE INTENDED USE WHEN EMPLOYED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED. 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 THE KNOB ON THE SELF-RETAINING SLEEVE OF A SCREWDRIVER FOR 4.5MM TITANIUM MULTILOC SCREWS BROKE OFF DURING A LEFT HUMERAL NAILING PROCEDURE ON (B)(6) 2016. AFTER A MULTILOC HUMERAL NAIL WAS INSERTED INTO THE HUMERUS, AS THE SURGEON WENT TO DISENGAGE THE SELF-RETAINING SLEEVE PORTION OF THE SCREWDRIVER FROM THE MULTILOC SCREW, THE KNOB ON THE SLEEVE BROKE OFF OUTSIDE OF THE PATIENT. A CLAMP WAS USED TO REMOVE THE SELF-RETAINING SLEEVE FROM THE MULTILOC SCREW. THERE WAS A REPORTED APPROXIMATE THIRTY (30) SECOND SURGICAL DELAY. NO ADDITIONAL X-RAYS OR MEDICAL INTERVENTION WERE REQUIRED. THE FINAL CONSTRUCT INCLUDED A MULITLOC HUMERAL NAIL AND MULTILOC SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. THIS COMPLAINT INVOLVES ONE DEVICE CONCOMITANT DEVICES REPORTED: MULTILOC SCREW (PART #UNKNOWN, LOT #UNKNOWN, QUANTITY 1), AIMING ARM (PART #03.019.012, LOT #UNKNOWN, QUANTITY 1), MULTILOC HUMERAL NAIL (PART #04.017.225S, LOT #UNKNOWN, QUANTITY 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848766 SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM SCREWDRIVERS HXX SYNTHES HAGENDORF 8993496 10886982069641

    Patients

    Seq Age Sex Outcome Treatment
    1 AIMING ARM PART #03.019.012 LOT # UNK, QTY 1| MULTILOC HUMERAL NAIL PART 04.017.225S, LOT UNK| MULTILOC SCREW PART & LOT # UNK, QTY 1