BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS®/DCS® LAG SCREW 12.7MM THREAD/90MM-STERILE

    MDR report key: 6952366 · Received October 16, 2017

    Report

    Report Number
    3009450863-2017-10030
    Event Type
    Malfunction
    Date Received
    October 16, 2017
    Date of Event
    September 1, 2017
    Report Date
    September 22, 2017
    Manufacturer
    SYNTHES BALSTHAL
    Product Code
    KTT
    PMA / PMN Number
    K791619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT ID WAS NOT PROVIDED FOR REPORTING. 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. THE INVESTIGATION SUMMARY INDICATES THAT THE: RECEIVED PART: 1 X 280.900S/DHS/DCS-SCR Ø12.5 L90 SST/LOT NO. 9233942. OUR INVESTIGATION HAS SHOWN THAT THE POSITIONING GROOVE OF THE SCREW IS EXPANDED AND DAMAGED. THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS PER THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE MEASURABLE DIMENSIONS OF THE DHS/DCS SCREW WERE AS FAR AS POSSIBLE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE OUTSIDE DIAMETER WITH TOLERANCE DIMENSION OF MAX. AND MIN. AMOUNTS WAS MEASURED WITH THE DIMENSION RESULT AND PASSED, THEREFORE, THE REQUIRED DIMENSION IS SUCCESSFUL ACCORDING DRAWING. THE MEASUREMENT OCCURRED WITH MICROMETER, UNFORTUNATELY, WE ONLY HAVE LIMITED INFORMATION IN THE COMPLAINT DESCRIPTION AND CANNOT CONFIRM HOW THIS HAPPENED. IT IS LIKELY THAT THE CONNECTION BETWEEN THE WRENCH AND THE SCREW WAS NOT ALIGNED AS INTENDED AND THEREFORE THIS OCCURRENCE IN COMBINATION WITH A MECHANICAL OVERLOAD SITUATION COULD HAVE LED TO THE COMPLAINT CONDITION. THIS RELATION TO THE SURGICAL TECHNIQUE: ¿WARNING: TO AVOID DAMAGING THE INSTRUMENTS AND THE IMPLANT, TIGHTEN THE CONNECTING SCREW SECURELY.¿ NOTED, IN ORDER TO PREVENT SUCH OCCURRENCE AND TO ENSURE A CORRECT LOAD TRANSFER IT IS CRUCIAL TO HAVE AN APPROPRIATE CONNECTION BETWEEN THE DHS-SCREW AND THE CONNECTING SCREW 338.310, WHICH IS GUIDED THROUGH THE WRENCH 338.300. NO PRODUCT FAULT COULD BE FOUND. FINALLY, WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCE'S. NO PRODUCT FAULT COULD BE DETECTED. DEVICE 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

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: 280.900S / 9233942. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 12.NOV.2014 EXPIRY DATE: 01.NOV.2024. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING PROCEDURE ON (B)(6) 2017, A MALE PATIENT, VICTIM OF A SCOOTER ACCIDENT, PRESENTING WITH A SUBTROCHANTERIC FRACTURE OF THE LEFT FEMUR. IT WAS NOT POSSIBLE TO IMPLANT THE DYNAMIC HIP SYSTEM (DHS) SCREW. THE SCREW DID NOT FIT INTO THE PLATE. THEY USED THE SAME SCREW FROM A DIFFERENT LOT TO COMPLETE THE PROCEDURE. THE SURGERY WAS PROLONGED ABOUT 15 MINUTES. NO INFORMATION AVAILABLE ABOUT PATIENT CONDITION AND OUTCOME. THERE WAS NO PATIENT HARM AND NO FRAGMENTS WERE GENERATED. THIS COMPLAINT INVOLVES 1 PART. CONCOMITANT REPORTED PART: 1X UNKNOWN DHS PLATE. THIS REPORT IS 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731740 DHS®/DCS® LAG SCREW 12.7MM THREAD/90MM-STERILE APPLIANCE,FIXATION,NAIL KTT SYNTHES BALSTHAL 9233942

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR