BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5100543 · Received September 24, 2015

    Report

    Report Number
    2520274-2015-16076
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Report Date
    September 15, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. BOYLE, M; GAO, R; FRAMPTON, C AND COLEMAN, B. (2014). REMOVAL OF THE SYNDESMOTIC SCREW AFTER THE SURGICAL TREATMENT OF A FRACTURE OF THE ANKLE IN ADULT PATIENTS DOES NOT AFFECT ONE-YEAR OUTCOMES. BONE JOINT J, 96-B, 1699¿1705. THIS REPORT IS FOR UNKNOWN (4MM CORTICAL SCREWS) /UNKNOWN QUANTITY/UNKNOWN LOT. 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE BOYLE, M; GAO, R; FRAMPTON, C AND COLEMAN, B. (2014). REMOVAL OF THE SYNDESMOTIC SCREW AFTER THE SURGICAL TREATMENT OF A FRACTURE OF THE ANKLE IN ADULT PATIENTS DOES NOT AFFECT ONE-YEAR OUTCOMES. BONE JOINT J, 96-B, 1699-1705. THE PURPOSE OF THIS ARTICLE WAS TO COMPARE THE FUNCTIONAL, CLINICAL AND RADIOLOGICAL OUTCOMES BETWEEN RETENTION AND REMOVAL GROUPS OF ADULT PATIENTS WHO WERE MANAGED WITH OSTEOSYNTHESIS AND SYNDESMOTIC SCREW FIXATION FOR A DISPLACED FRACTURE OF THE ANKLE WITH ASSOCIATED INSTABILITY OF THE SYNDESMOSIS AND WERE RANDOMISED TO BE FURTHER MANAGED WITH REMOVAL OR RETENTION OF THE SYNDESMOTIC SCREW. 25 PATIENTS PARTICIPATED FROM THE RETENTION GROUP AND 26 IN THE REMOVAL GROUP COMPLETING ONE YEAR OF FOLLOW-UP. THIS IS REPORT 4 OF 6 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN 4MM CORTICAL SCREWS AND REFERS TO SCREW BREAKAGE IN A (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632211 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR