BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANNULATED SMARTSCREW, 4.5X60MM

    MDR report key: 1308403 · Received February 3, 2009

    Report

    Report Number
    9613278-2009-00003
    Event Type
    Injury
    Date Received
    February 3, 2009
    Date of Event
    November 15, 2008
    Report Date
    January 5, 2009
    Manufacturer
    CONMED LINVATEC BIOMATERIALS LTD.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR HAS UNDERTAKEN A REVIEW OF THE MANUFACTURING AND COMPLAINT HISTORY RECORDS FOR THIS PRODUCT, INCLUDING THE SPECIFIC CATALOGUE NUMBER AND LOT NUMBER. A REVIEW OF SIMILAR REPORTS SINCE 1999 TO CURRENT DATE FOUND 2 OTHER EVENTS, MAKING THE RATE OF OCCURRENCE 0.022 PERCENT. THIS IS THE ONLY COMPLAINT RECEIVED FOR THIS LOT NUMBER. PT OUTCOME: PT WAS SEEN IN EARLY 2009 AND AT THIS TIME, THERE WERE NO NOTED PROBLEMS. A FOLLOW-UP VISIT IS SCHEDULED FOR 6 WEEKS.

    Description of Event or Problem · 1

    PT UNDERWENT SURGERY FOR A TRAUMATIC ANKLE FRACTURE IN 2008, USING A BIOABSORBABLE CANNULATED 4.5MM SMARTSCREW. THE SCREW WAS FIXED ACROSS THE DISTAL TIBIA AND FIBULA. THE PT HAD A COMPLAINT OF TIGHTNESS IN THE ANKLE JOINT SEVERAL MONTHS POST-OP AND RADIOGRAPHICAL INVESTIGATION WAS INCONCLUSIVE. THE SURGEON PERFORMED AN ARTHROSCOPIC PROCEDURE IN EARLY 2009, WHERE IT WAS NOTED THAT THE JOINT CAPSULE HAD SOME ADHESIONS WHICH WERE CONSIDERED TO BE NORMAL. NO INFLAMMATORY REACTIONS WERE NOTED AND THE SCREW INTEGRITY WAS NOT COMPROMISED. THE SURGEON DETERMINED THAT THE FRACTURE HAD HEALED WELL BUT, DURING THE PROCEDURE, THE SURGEON DECIDED TO REMOVE SOME OF THE SCREW (PROXIMAL HEAD AND SHAFT). THE SURGEON WAS CONFIDENT THAT THE SCREW WAS NOT THE CAUSE OF THE PT'S COMPLAINT. FRAGMENTS OF THE SCREW THAT WERE REMOVED WERE RETRIEVED AND RETURNED TO THE MFR FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULATED SMARTSCREW, 4.5X60MM SCREW, FIXATION, BONE HWC CONMED LINVATEC BIOMATERIALS LTD. NA S0002247

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other NK