BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5847773 · Received August 4, 2016

    Report

    Report Number
    2520274-2016-13790
    Event Type
    Injury
    Date Received
    August 4, 2016
    Report Date
    July 23, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. OTTO, D., PINCZEWSKI, L. A., CLINGELEFFER, A., ODELL, R. (1998) FIVE-YEAR RESULTS OF SINGLE-INCISION ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH PATELLAR TENDON AUTOGRAFT. THE AMERICAN JOURNAL OF SPORTS MEDICINE, VOL. 26, NO. 2, 181 ¿ 188. THIS REPORT IS FOR UNKNOWN AO 6.5-MM, FULLY THREADED, CANCELLOUS SCREW/UNKNOWN QUANTITY/UNKNOWN LOT / UDI # UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. (B)(4) PROTRUDING TIBIAL SCREWS. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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

    LITERATURE ARTICLE RECEIVED: THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: OTTO, D., PINCZEWSKI, L. A., CLINGELEFFER, A., ODELL, R. (1998) FIVE-YEAR RESULTS OF SINGLE-INCISION ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH PATELLAR TENDON AUTOGRAFT. THE AMERICAN JOURNAL OF SPORTS MEDICINE, VOL. 26, NO. 2, 181 - 188. AUSTRALIA. PURPOSE OF STUDY:THE PURPOSE OF THIS STUDY WAS TO REVIEW THE 5-YEAR CLINICAL AND RADIOGRAPHIC RESULTS USING THIS TECHNIQUE FOR ACL RECONSTRUCTION. THE AUTHORS PERFORMED A RETROSPECTIVE STUDY ON 80 PATIENTS WHO UNDERWENT SINGLE-INCISION ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH PATELLAR TENDON AUTOGRAFT AND INTERFERENCE FIT SCREW FIXATION IN 1989. TWELVE PATIENTS WERE LOST TO FOLLOW UP, ALLOWING A CLINICAL ASSESSMENT OF 68 PATIENTS TO BE CONDUCTED BY INDEPENDENT EXAMINERS AT 1 AND 5 YEARS AFTER SURGERY, WITH RADIOGRAPHIC ASSESSMENT AT 5 YEARS. PATIENT DEMOGRAPHICS: THE STUDY CONSISTED OF 80 PATIENTS, 12 WERE LOST TO FOLLOW UP. OF THE REMAINING 68, 49 WERE MEN AND 19 WERE WOMEN. THE AVERAGE AGE WAS 27 WITH A RANGE OF 15 - 46. THERE WERE 32 RIGHT AND 36 LEFT KNEES. PRODUCTS USED: AO 6.5-MM, FULLY THREADED, CANCELLOUS SCREW AND PATELLAR TENDON AUTOGRAFT. COMPLICATIONS REPORTED: SERIOUS INJURY/ REPORTABLE MALFUNCTION: FOUR PATIENTS HAD PROTRUDING TIBIAL SCREWS THAT REQUIRED REMOVAL AND ONE PATIENT DEVELOPED A SEPTIC ARTHRITIS THAT WAS TREATED WITH ARTHROSCOPIC LAVAGE, REMOVAL OF THE SCREWS, AND INTRAVENOUS ANTIBIOTICS. THE TREATMENT WAS EFFECTIVE AND THE JOINT REMAINED STABLE. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN AO 6.5-MM, FULLY THREADED, CANCELLOUS SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499189 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention