BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER UNIVERSAL LOCKING SYSTEM SCREW

    MDR report key: 2042242 · Received February 15, 2011

    Report

    Report Number
    1822565-2011-00558
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    April 20, 2010
    Report Date
    June 3, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE 2.7 MM LOCKING SCREW STATED IN THE COMPLAINT WAS RECEIVED. SEM EXAMINATION OF THE FRACTURE SURFACE OF THE SCREW HEAD SHOWED FOREIGN SUBSTANCE ON A LARGE PART OF THE FRACTURE SURFACE AND A CRACK AND PROPAGATED INTO THE SCREW HEAD BY CORROSION-FATIGUE. SCREW WAS IN VIVO FOR ELEVEN MONTHS. SURGICAL TECHNIQUE USED IS UNK, AND PT DETAILS ARE UNK. IT IS UNK HOW ONE SCREW GOT CORRODED. THERE HAVE BEEN NO INCIDENTS REPORTED SIMILAR TO THIS. THERE IS INSUFFICIENT INFO PROVIDED TO DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PLATE DID NOT FIND ANY DEVIATIONS OR ANOMALIES. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE SCREW WAS NOT POSSIBLE AS THE LOT NUMBER REQUIRED FOR RETRIEVAL WAS UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT ONE OF THE LOCKING SCREWS WAS CORRODED. WHILE TRYING TO REMOVE THE SCREW, THE HEAD BROKE OFF AND PART OF THE HEAD WAS LEFT LOCKED INTO THE PLATE. THE SURGEON WAS STILL ABLE TO REMOVE ALL THE SCREWS AND PLATE FROM THE PT. THIS WAS THE ONLY SCREW THAT WAS CORRODED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER UNIVERSAL LOCKING SYSTEM SCREW HWC ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR