BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DVR EPAK VOLAR RIM PLATE LEFT

    MDR report key: 4950139 · Received July 29, 2015

    Report

    Report Number
    0001825034-2015-03394
    Event Type
    Injury
    Date Received
    July 29, 2015
    Date of Event
    July 6, 2015
    Report Date
    October 31, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXT
    PMA / PMN Number
    PK132704
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    DURING REMEDIATION, IT WAS NOTED THAT THIS EVENT SHOULD NOT HAVE BEEN VOIDED, AS PREVIOUSLY REPORTED. PRODUCT WAS NOT RETURNED TO ZIMMER BIOMET, BUT BASED ON THE INSPECTION FINDINGS WITH PART INFORMATION, IT WAS DETERMINED THAT THE ROOT CAUSE IS ASSOCIATED WITH THE RADEL MATERIAL THAT IS USED IN THE PLASTIC COMPONENTS IN THE KIT. THERE IS CHLORINE RELEASING FROM THE RADEL MATERIAL IN PARTS PER MILLION, DURING GAMMA STERILIZATION, THAT RESULTS IN OXIDATION OF THE DRILL BITS WHEN EXPOSED TO EXTREME ENVIRONMENTAL CONDITIONS SUCH AS THOSE EXPERIENCED DURING TRANSPORT. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED AN ISSUE THAT IS BEING ADDRESSED IN (B)(4). REVIEW OF DEVICE HISTORY RECORDS FOUND THAT THIS UNIT WAS RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION PROCEDURE ON (B)(6) 2015. DURING THE PROCEDURE, RUST-LIKE MATERIAL WAS SEEN ON THE DRILL BIT SURFACE SET. SUBSEQUENTLY, EVERY IMPLANT AND INSTRUMENT IN THE KIT WAS STERILIZED BY AUTOCLAVE. AS A RESULT, THERE WAS A SURGICAL DELAY OF ABOUT 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493455 DVR EPAK VOLAR RIM PLATE LEFT APPLIANCE, FIXATION LXT BIOMET ORTHOPEDICS N/A 214098

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R