BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5326792 · Received December 24, 2015

    Report

    Report Number
    2520274-2015-18102
    Event Type
    Malfunction
    Date Received
    December 24, 2015
    Date of Event
    December 8, 2015
    Report Date
    December 8, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR ONE (1) UNKNOWN LOCKING SCREW. A PARTIAL PART NUMBER WAS IDENTIFIED AS 212.8XX. INFORMATION PERTAINING TO THIS PART FAMILY IS AS FOLLOWS: 2.4MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 10MM. ADDITIONAL PRODUCT CODES, BASED UPON THE PARTIAL PART FAMILY, FOR THIS REPORT INCLUDE HRS. THE COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. BASED UPON THE PARTIAL PART NUMBER PROVIDED, THE LIKELY 510K NUMBER FOR THE DEVICE IS K102694. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A TEMPORARY WRIST SPANNING INTERNAL FIXATION CONSTRUCT ON AN UNKNOWN DATE DUE TO A WRIST FRACTURE. THE CONSTRUCT CONSISTED OF A 2.4MM LOCKING COMPRESSION (LCP) STRAIGHT WRIST PLATE AND SIX (6) LOCKING SCREWS. PART OF THE TREATMENT PLAN WAS TO REMOVE THE HARDWARE ON (B)(6) 2015. THE PATIENT UNDERWENT THE HARDWARE REMOVAL AS SCHEDULED. DURING THE REMOVAL PROCESS, THE SURGEON EXPERIENCED DIFFICULTY EXPLANTING ONE (1) OF THE 2.4MM LOCKING SCREWS FROM THE PLATE. THE SURGEON ATTEMPTED TO PRY AND PULL THE PLATE. UPON REMOVAL, IT WAS NOTED THAT THE SCREW, IN ITS ENTIRETY, REMAINED STUCK IN THE PLATE'S SCREW HOLE. A SURGICAL DELAY OF AN UNKNOWN LENGTH WAS NOTED. THE REMAINING FIVE (5) SCREWS WERE REMOVED WITHOUT DIFFICULTY. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THIS REPORT IS FOR ONE (1) UNKNOWN LOCKING SCREW. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850683 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1