BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4999520 · Received August 13, 2015

    Report

    Report Number
    2520274-2015-15115
    Event Type
    Injury
    Date Received
    August 13, 2015
    Report Date
    July 20, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    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. WINSON, L.G., ROBINSON, D.E. AND ALLEN, P.E. (2005). ARTHROSCOPIC ANKLE ARTHRODESIS. THE JOURNAL OF BONE AND JOINT SURGERY, 87-B, 343-347. THIS REPORT IS FOR UNKNOWN (2) CANNULATED PERCUTANEOUS ACE 6.5MM SCREWS /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: WINSON, L.G., ROBINSON, D.E. AND ALLEN, P.E. (2005). ARTHROSCOPIC ANKLE ARTHRODESIS. THE JOURNAL OF BONE AND JOINT SURGERY, 87-B, 343-347. BETWEEN OCTOBER 1991 AND APRIL 2002, 116 PATIENTS UNDERWENT 118 ARTHROSCOPIC ANKLE ARTHRODESES. THERE WERE 71 MEN AND 45 WOMEN; THE MEAN AGE AT OPERATION WAS 57 YEARS 2 MONTHS (20 TO 86 YEARS). THREE PATIENTS WERE LOST TO FOLLOW-UP. COMPLICATIONS: 22-PATIENTS REQUIRING REMOVAL OF SCREWS DUE TO PROMINENCE, 9-PATIENTS NON-UNION, 1- DEEP INFECTION, 1-PATIENT REVISION OF FIXATION DUE TO POSITIONING, 1-PATIENT STRESS FRACTURE AT THE LEVEL OF THE PROXIMAL SCREW HEAD. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT OF 1 OF 1 FOR COMPLAINT (B)(4). THIS REPORT IS FOR AN UNKNOWN (2) CANNULATED PERCUTANEOUS ACE 6.5MM SCREWS (DEPUY INTERNATIONAL) AND REFERS TO THE SERIOUS INJURY OF 34 PATIENTS THAT EXPERIENCED: 22-PATIENTS REQUIRING REMOVAL OF SCREWS DUE TO PROMINENCE, 9-PATIENTS NON-UNION, 1- DEEP INFECTION,1-PATIENT REVISION OF FIXATION DUE TO POSITIONING, 1-PATIENT STRESS FRACTURE AT THE LEVEL OF THE PROXIMAL SCREW HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533638 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention