BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM CORTICAL SCREW

    MDR report key: 1252424 · Received December 3, 2008

    Report

    Report Number
    2648920-2008-00055
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    September 18, 2008
    Report Date
    November 3, 2008
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    HWC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: BASED ON THE INFORMATION PROVIDED IT IS UNKNOWN AS TO HOW MANY SCREWS WERE USED AND HOW THE FIXATION OF THE PLATE WAS MADE TO THE ANKLE BONE. ALSO, THERE WERE NO X-RAYS AND/OR PHOTOS RETURNED FOR REVIEW. PATIENT MIGHT HAVE EXPERIENCED PAIN DUE TO INADEQUATE HEALING OF THE BONE OR NON-COMPLIANCE REASONS. PATIENT WEIGHT MAY HAVE ALSO CONTRIBUTED TO THIS EVENT. BASED ON THE INFORMATION PROVIDED THE CAUSE CAN NOT BE DEFINITELY DETERMINED. EVALUATION: NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE REVIEWED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE PATIENT'S ATTORNEY THAT THE PATIENT UNDERWENT RIGHT ANKLE SURGERY IN 2006. POST-OP, PATIENT WAS EXPERIENCING PAIN, AND X-RAYS TAKEN THREE MONTHS LATER, SHOW THE SYNDESMOSIS SCREW HAD BROKEN. REMOVAL OF THE ENTIRE BROKEN SCREW WAS PERFORMED THE FOLLOWING MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM CORTICAL SCREW TRAUMA PROSTHESIS HWC ZIMMER MANUFACTURING B.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R