BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS®/DCS® LAG SCREW 12.7MM THREAD/105MM

    MDR report key: 6654783 · Received June 20, 2017

    Report

    Report Number
    3009450863-2017-10017
    Event Type
    Malfunction
    Date Received
    June 20, 2017
    Date of Event
    May 31, 2017
    Report Date
    May 31, 2017
    Manufacturer
    SYNTHES BALSTHAL
    Product Code
    KTT
    UDI-DI
    07611819012554
    PMA / PMN Number
    K791619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS PERFORMED ON SUBJECT DEVICE DHS/DCS-SCR Ø12.5 L105 SST (PART # 280.050, LOT # L021728). THE DEVICE WAS RECEIVED WITH THE POSITIONING GROOVE OF THE DHS/DCS SCREW IS EXPANDED AND DAMAGED. THE MEASURABLE DIMENSIONS OF THE DHS-SCREW WERE AS FAR AS POSSIBLE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AT TIME OF MANUFACTURING. THE EXTERNAL DIAMETER WITH A TOLERANCE WAS MEASURED AND WAS FOUND ACCORDING SPECIFICATION. SUPPLEMENTAL DIMENSIONAL CHECK BETWEEN THE TWO OUTER SURFACES WAS PERFORMED AT DAMAGED AND UNDAMAGED AREA WITH THE RESULT THAT UNDAMAGED AREA DOES MEET SPECIFICATION. UNFORTUNATELY WE ONLY HAVE LIMITED INFORMATION IN THE COMPLAINT DESCRIPTION AND CANNOT CONFIRM HOW THIS HAPPENED. ALSO WE DID NOT HAVE RECEIVED THE INVOLVED PLATE FOR INVESTIGATION WHICH MAKES A FINAL DETERMINATION VERY DIFFICULT. BASED ON THE INVESTIGATION RESULTS WE CAN ONLY SUPPOSE 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 LEAD TO THE MALFUNCTION OF THE DEVICES. PLEASE NOTE, 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 DETECTED 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DATE OF THIS REPORT: INITIAL REPORTED AS JUNE 01, 2017, BUT SHOULD HAVE BEEN MAY 31, 2017. 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

    PATIENT¿S IDENTIFIER, DATE OF BIRTH AND WEIGHT ARE UNKNOWN. DUE TO THE INTRA-OPERATIVE EVENTS, THE DEVICE WAS NOT SUCCESSFULLY IMPLANTED. AN ALTERNATE DEVICE WAS USED TO COMPLETE PROCEDURAL STEP. AS SUCH, IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER TELEPHONE NUMBER: (B)(6). A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART # 280.050, LOT # L021728: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 24.AUG.2016: NO NON CONFORMANCE REPORTS (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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2017, THE SCRUB NURSE TRIED TO PASS THE DYNAMIC HIP SYSTEM (DHS) SCREW INTO THE PLATE AND IT DID NOT PASS THROUGH THE PLATE. THEREFORE SURGEON HAD TO USE ANOTHER SCREW TO CONTINUE THE SURGERY. THE SCRUB NURSE JUST TESTED THE SCREW THROUGH THE PLATE BEFORE ANY CONTACT WITH THE PATIENT. THERE WAS NO SURGICAL DELAY REPORTED AS THE TEAM WAS VERY EFFICIENT. CONCOMITANT PARTS REPORTED: PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) DHS®/DCS® LAG SCREW 12.7MM THREAD/105MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434518 DHS®/DCS® LAG SCREW 12.7MM THREAD/105MM APPLIANCE,FIXATION,NAIL KTT SYNTHES BALSTHAL L021728 07611819012554

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR