BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER

    MDR report key: 3905173 · Received July 1, 2014

    Report

    Report Number
    2520274-2014-12198
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Report Date
    June 11, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. LEHMEN, J., DELLA ROCCA, G., MURTHA, Y., CRIST, B. (2011) REMOVAL TECHNIQUE FOR COLD-WELDED TITANIUM LOCKING SCREWS. INJURY, INT. J. CARE INJURED 42:1377-1379. THIS REPORT IS FOR AN UNKNOWN LESS INVASIVE STABILIZATION SYSTEM PLATE. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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. 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: REMOVAL TECHNIQUE FOR COLD-WELDED TITANIUM LOCKING SCREWS. LEHMEN, J., DELLA ROCCA, G., MURTHA, Y., CRIST, B. (2011) REMOVAL TECHNIQUE FOR COLD-WELDED TITANIUM LOCKING SCREWS. INJURY, INT. J. CARE INJURED 42:1377-1379. A (B)(6) EMACIATED MALE WITH A HISTORY OF SMOKING AND POOR NUTRITION SUCCESSFULLY HEALED HIS LEFT AO/OTA 33-C3 OPEN DISTAL FEMUR FRACTURE AND BIMALLEOLAR ANKLE FRACTURE. THE PATIENT HAD A PERSISTENT TIBIAL NONUNION WITH MAIN COMPLAINTS OF TIBIAL PAIN AND A PAINFUL SCREW THAT WAS PALPABLE OVER HIS DISTAL FEMUR MEDIALLY. TO ADDRESS THE ISSUES, THE PLAN WAS TO REMOVE THE PROMINENT DISTAL FEMUR SCREW, REMOVE THE TIBIAL LESS INVASIVE STABILIZATION SYSTEM (LISS) PLATE (SYNTHES), AND REPAIR THE TIBIAL NONUNION WITH A REAMED INTRAMEDULLARY NAIL. DURING THE REMOVAL OF THE TIBIAL LISS PLATE, FOUR SYNTHES STAR DRIVE SCREW DRIVERS BROKE, CONICAL EXTRACTION SCREWS FAILED, AND A STAR DRIVE SHAFT THAT WAS CONNECTED TO A COMPETITOR'S UNIVERSAL T-HANDLE CHUCK JUNCTION FAILED. AS A LAST RESORT, THE HEAD OF EACH OF THE THREE PROXIMAL SCREWS WAS REMOVED WITH A CARBIDE BURR. A SIGNIFICANT AMOUNT OF METAL DEBRIS WAS GENERATED WHICH REQUIRED A SIGNIFICANT AMOUNT OF TIME TO REMOVE. AFTER ALL THE SCREWS WERE REMOVED, THE PLATE WAS REMOVED AND A TREPHINE WAS USED TO REMOVE THE REMAINING PROXIMAL BROKEN SCREW SHAFTS. THIS REPORT IS 3 OF 3 FOR COMPLAINT (B)(4). THIS REPORT IS FOR FOUR UNKNOWN SCREWDRIVERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383090 SCREWDRIVER HXX SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR