BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5427838 · Received February 10, 2016

    Report

    Report Number
    2520274-2016-10924
    Event Type
    Injury
    Date Received
    February 10, 2016
    Report Date
    January 27, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NO DIAGNOSIS. PATIENT IDENTIFIER, AGE, AND WEIGHT NOT PROVIDED. "A COMPARISON OF K-WIRE VERSUS SCREW FIXATION ON THE OUTCOMES OF DISTAL PHALANX FRACTURES" (2015). HAY, R.A.S. & TAY, S.C. THE JOURNAL OF HAND SURGERY (2015; 40(11):2160-2167). THIS REPORT IS FOR AN UNKNOWN SCREW/UNKNOWN QUANTITY/UNKNOWN LOT. UNKNOWN PART NUMBER, UDI UNAVAILABLE 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, "A COMPARISON OF K-WIRE VERSUS SCREW FIXATION ON THE OUTCOMES OF DISTAL PHALANX FRACTURES" (2015). HAY, R.A.S. & TAY, S.C. THE JOURNAL OF HAND SURGERY (2015; 40(11):2160-2167). THE COUNTRY OF ORIGIN IS (B)(6). A RETROSPECTIVE REVIEW OF CLINIC PATIENTS WITH DISTAL PHALANX FRACTURES BETWEEN THE YEARS OF 2007 AND 2013. OF 141 PATIENTS, 31 PATIENTS HAD SURGERY FOR 33 DISTAL PHALANX FRACTURES. TWELVE OF THE FRACTURES HAD K-WIRE AND 21 HAD SCREW FIXATION. THERE WERE 12 MALES WITH A MEAN AGE OF 39.8 YEARS WHO HAD THE K-WIRE FIXATION AND 20 MALES WITH A MEAN AGE OF 35.1 YEARS WHO HAD SCREW FIXATION. OF THE 21 PATIENTS THAT HAD FIXATION WITH SCREWS, NINE MALES HAD THE SCREWS EXPLANTED DUE TO TENDERNESS IN THE FINGERTIP. THIS REPORT IS 4 OF 10 (B)(4). THIS REPORT IS FOR AN UNKNOWN SCREW AND REFERS TO A MALE PATIENT WHO HAD SCREWS EXPLANTED DUE TO TENDERNESS IN THE FINGERTIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84485 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention