BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM

    MDR report key: 6729170 · Received July 20, 2017

    Report

    Report Number
    3003875359-2017-10345
    Event Type
    Malfunction
    Date Received
    July 20, 2017
    Date of Event
    June 23, 2017
    Report Date
    June 23, 2017
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED TO MANUFACTURER. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART # 03.010.486, LOT # 9200411: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 20.JAN.2015: 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. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED ON THE RETURNED SUBJECT DEVICE. FOR THE REPORTED CONDITION OF MISALIGNMENT, THIS COMPLAINT WAS UNABLE TO BE CONFIRMED AS ALL THE DEVICES USED IN THE CONSTRUCT WERE NOT RETURNED FOR EVALUATION AND NO DAMAGE THAT WOULD CONTRIBUTE TO MISALIGNMENT WAS OBSERVED. HOWEVER, IT IS CONFIRMED AT CUSTOMER QUALITY (CQ) THAT THE THUMB SCREW COMPONENT IS MISSING FROM THE AIMING ARM (PART# 03.010.052). THE COMPLAINT CONDITION OF MISALIGNMENT WAS NOT ABLE TO BE REPLICATED AT CUSTOMER QUALITY (CQ) AS ALL THE DEVICES USED IN THE CONSTRUCT WERE NOT RETURNED FOR EVALUATION. NO NEW MALFUNCTIONS WERE IDENTIFIED AS A RESULT OF THE INVESTIGATION. A VISUAL INSPECTION UNDER 5X MAGNIFICATION, DEVICE HISTORY RECORD (DHR) REVIEW AND DRAWING REVIEW WERE PERFORMED AT CQ FOR THE RETURNED DEVICES AS PART OF THIS INVESTIGATION. THE RETURNED DEVICES ARE USED TOGETHER IN THE TITANIUM CANNULATED TIBIAL NAIL- EXPERT SYSTEM AND ARE INTENDED FOR TARGETING FOR THE PROXIMAL LOCKING OPTIONS PER THE RELEVANT TITANIUM CANNULATED TIBIAL NAILS TECHNIQUE GUIDE. UNABLE TO DETERMINE A ROOT CAUSE FOR THIS COMPLAINT. TO ENSURE PROPER ALIGNMENT IT IS IMPORTANT TO HAVE ALL COMPONENTS TIGHTLY CONNECTED AND TO NOT APPLY EXTERNAL FORCES TO THE CONSTRUCT. IT IS POSSIBLE THAT HAMMERING FOR NAIL INSERTION AND/OR FORCEFUL MANIPULATION OF THE DEVICES LOOSENED THE CONSTRUCT AND/OR FORCED THE DEVICES OUT OF ALIGNMENT. THE TECHNIQUE GUIDE RECOMMENDS THAT THE USER ¿CONFIRM THAT THE NAIL IS SECURELY CONNECTED TO THE INSERTION HANDLE, ESPECIALLY AFTER HAMMERING¿ AND NOTES "DO NOT EXERT FORCES ON THE AIMING ARM, PROTECTION SLEEVE, DRILL SLEEVES AND DRILL BITS. THESE FORCES MAY PREVENT ACCURATE TARGETING THOUGH THE PROXIMAL LOCKING HOLES AND DAMAGE THE DRILL BITS." HOWEVER, AS THE APPLICATION OF FORCES AND TECHNIQUE USED ARE UNKNOWN THE ROOT CAUSE CANNOT BE DEFINITIVELY DETERMINED. NO DAMAGE THAT WOULD CONTRIBUTE TO MISALIGNMENT WAS OBSERVED FOR PART# 03.010.486 (RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM). RELEVANT DRAWINGS WERE REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. 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 IDENTIFIER AND WEIGHT NOT AVAILABLE FOR REPORTING. UDI: (B)(4). IMPLANT AND EXPLANT DATES: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A RIGHT TIBIA SHAFT FRACTURE, THE ALIGNMENT OF THE INSERTION HANDLE AND AIMING ARM WAS NOTED AS BEING SLIGHTLY OFF, THE DRILL BIT TO STRIKE THE NAIL AND PREVENTED THE SCREW FROM GOING INTO THE HOLE OF THE NAIL. THE DEVICES WERE VISIBLY NOT CENTERED ON THE PATIENT¿S LEG. THE MISALIGNMENT WAS SLIGHT WHICH ALLOWED THE SURGEON TO APPLY FORCE IN ORDER TO GET THE SCREW THROUGH THE HOLE OF THE NAIL. THERE WAS NO SURGICAL DELAY. ROUTINE INTRAOPERATIVE X-RAYS WERE TAKEN AS STANDARD FOR THE PROCEDURE. THE SURGEON WAS SATISFIED WITH PLACEMENT OF THE NAIL AND SCREW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: A 10MM TI CANNULATED TIBIAL NAIL-EX/330MM-STERILE (PART 04.004.446S, LOT 9870686, QUANTITY 1); 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM FOR IM NAILS (PART 04.005.530, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509636 RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 9200411

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR