BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4622564 · Received March 23, 2015

    Report

    Report Number
    2520274-2015-11943
    Event Type
    Malfunction
    Date Received
    March 23, 2015
    Report Date
    February 25, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SCREW. 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. 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, VALKERING, K.P., VAN DEN BEKEROM, M.P., KAPPELHOFF, F.M., AND ALBERS, G.H. (2009). COMPLICATIONS AFTER TOMOFIX MEDIAL OPENING WEDGE HIGH TIBIAL OSTEOTOMY. THE JOURNAL OF KNEE SURGERY, 22 (3) 218-225). THIS ARTICLE DESCRIBES THE COMPLICATIONS AFTER MEDIAL OPENING WEDGE HIGH TIBIAL OSTEOTOMY (HTO) WITH THE SYNTHES TOMOFIX PLATE. BETWEEN (B)(6) 2003 AND (B)(6) 2005, 39 PATIENTS WERE TREATED FOR UNICOM-PARTMENTAL MEDIAL OSTEOARTHRITIS OF THE KNEE WITH A VARUS DEFORMITY. ONE PATIENT UNDERWENT BILATERAL OPERATION WITH AN INTERVAL OF 6 MONTHS. THE GROUP OF PATIENTS COMPRISED 14 WOMEN AND 25 MEN. THE MEAN AGE OF THE PATIENTS WAS 47 YEARS (RANGE, 24-67 YEARS). ALL PATIENTS WERE ASSESSED RETROSPECTIVELY. ON AVERAGE, RADIOLOGICAL CONSOLIDATION WAS REACHED AFTER 10.4 MONTHS. NON-UNIONS WERE NOT RECORDED. IN 4 CASES (10%), A SUPERFICIAL INFECTION WAS FOUND. ALL PATIENTS WERE TREATED WITH INTRAVENOUS ANTIBIOTICS AND WITH CONVALESCENCE THEREAFTER. IN 1 PATIENT, WOUND DRAIN¬AGE OCCURRED 2 WEEKS POSTOPERATIVELY DUE TO A HEMATOMA. THERE WAS GOOD RECOVERY WITH ORAL ANTIBIOTICS. IN 37 CASES, THE IMPLANT WAS EXTRACTED AFTER AN AVERAGE OF 14 MONTHS (RANGE, 6-27 MONTHS). IN 1 PATIENT, 1 SCREW BROKE WHEN THE TOMOFIX PLATE WAS REMOVED AFTER 12 MONTHS. BECAUSE OF PERSISTING COMPLAINTS, 1 OSTEOCHONDRAL AUTOGRAFT TRANSFER SYSTEM WAS PERFORMED AFTER 25 MONTHS, 1 MEDIAL UNICONDYLAR KNEE PROSTHESIS WAS IMPLANTED AFTER 14 MONTHS, AND 1 TOTAL KNEE ARTHROPLASTY WAS IMPLANTED AFTER 16 MONTHS. THIS REPORT IS FOR AN UNKNOWN SCREW AND REFERS TO THE REPORTABLE MALFUNCTION OF ONE PATIENT IN WHICH ONE SCREW BROKE WHEN THE TOMOFIX PLATE WAS REMOVED AFTER 12 MONTHS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4). A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193375 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1