BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM TI VA-LCP 2-COL DSTL RADPL NRW 6H HD/2H SHAFT/LT-STER

    MDR report key: 5856867 · Received August 9, 2016

    Report

    Report Number
    1000562954-2016-10168
    Event Type
    Malfunction
    Date Received
    August 9, 2016
    Date of Event
    July 14, 2016
    Report Date
    July 14, 2016
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    HRS
    PMA / PMN Number
    K092556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. ADDITIONAL DEVICE PRODUCT CODE IS HWC. (B)(4). (B)(6). THE COMPLAINT DEVICE IS NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE COMPLAINT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE COMPLAINT DEVICE. THE 22 PIECE LOT WAS MANUFACTURED IN (B)(4) AND WAS STERILIZED BY SUPPLIER, (B)(4). MANUFACTURING DATE: NOV 10, 2015. EXPIRY DATE: NOV 1, 2025. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 WHEN ATTEMPTING TO LOCK THE SCREW, A TORQUE LIMITER WAS USED. THERE WAS NO ISSUE REPORTED WITH THE TORQUE LIMITER. IT WAS ALSO NOTED THAT THE PLATE REMAINS IMPLANTED. CONCOMITANT DEVICE: TORQUE LIMITER (PART 511.776, LOT UNKNOWN, QUANTITY 1).

    Description of Event or Problem · 1

    SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY FOR FRACTURE OF LEFT DISTAL RADIUS ON (B)(6) 2016., THE REPORTED VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) BUTTRESS PIN PENETRATED THROUGH THE REPORTED LOCKING COMPRESSION PLATE. DURING THE SURGERY, THE SURGEON INSERTED ALL VA SCREWS THROUGH GUIDING BLOCK AT STABLE ANGLE. THE SURGEON REPORTED THAT WHEN TIGHTENING THE VA SCREW IN THE RADIUS SIDE OF THE DISTAL PLATE HOLE, THE SCREW DID NOT FEEL AS IF IT "CAUGHT" INTO THE PLATE HOLE. ALTHOUGH THE SURGEON TRIED TO TIGHTEN THE SCREW AGAIN, THE ATTEMPT DID NOT WORK AND THE SURGEON LEFT THE SCREW IN THE HOLE. WHEN THE SURGEON TRIED TO INSERT THE VA LOCKING BUTTRESS PIN INTO THE DISTAL SECOND HOLE OF THE REPORTED PLATE THE SURGEON AGAIN DID NOT FEEL THE PIN WAS "CAUGHT" IN THE PLATE HOLE. THE SURGEON THEN CHECKED THE HEAD OF THE PIN AND FOUND THE PIN WAS PENETRATING THROUGH THE PLATE HOLE. THE SURGEON REMOVED THE PINS FROM THE PLACED SITE AND AGAIN PLACED THE PLATE AND INSERTED SCREWS INSTEAD OF THE PIN INTO PLATE HOLES EXCEPT FOR THE PREVIOUSLY MENTIONED PENETRATED HOLE. THE SURGEON USED AND LOCKED, AN UNKNOWN LOCKING SCREW (2.4MM) TO THE PENETRATED HOLE DUE TO THE BIG SIZED SCREW HEAD. THE SURGERY WAS COMPLETED BUT WAS DELAYED 20 MINUTES DUE TO THE REPORTED EVENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515372 2.4MM TI VA-LCP 2-COL DSTL RADPL NRW 6H HD/2H SHAFT/LT-STER PLATE, FIXATION, BONE HRS SYNTHES MEZZOVICO 9710733

    Patients

    Seq Age Sex Outcome Treatment
    1