BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZIMMER DRILL STOP KIT

    MDR report key: 2560368 · Received May 21, 2010

    Report

    Report Number
    2023141-2010-00003
    Event Type
    Other
    Date Received
    May 21, 2010
    Date of Event
    May 11, 2010
    Report Date
    May 20, 2010
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZA
    PMA / PMN Number
    JTF #92
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PART NO: (B)(4), LOT NO: 61482528, TOTAL QUANTITY PRODUCED: (B)(4) (MFG DATE 3/20/2010); DSKIT, (B)(4) (MFG DATE 3/26/2010); (B)(4) (MFG DATE 4/16/2010); (B)(4) (MFG DATE 3/17/2010) - NO EXP DATE. INCOMPLETE STERILIZATION COULD LEAD TO CROSS CONTAMINATION OF MULTIPLE PTS. TESTING ON A PROTOTYPE PART WITH SIMILAR FEATURES CAME BACK SHOWING THAT STERILITY MAY BE COMPROMISED AT THE LID-KIT INTERFACE LOCATION, IDENTIFIED BY THE MFR.

    Description of Event or Problem · 1

    AS IDENTIFIED BY THE MFR: INSTRUCTIONS FOR USE CONTAIN PRE-VACUUM STERILIZATION INSTRUCTIONS THAT MAY LEAD TO COMPROMISED STERILITY AT THE LID-KIT INTERFACE LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER DRILL STOP KIT DRILL STOP KIT DZA ZIMMER DENTAL DSKIT 61482528

    Patients

    Seq Age Sex Outcome Treatment
    1 NA