BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL, AO, STERILE 4, 2X340 MM

    MDR report key: 2308670 · Received September 23, 2011

    Report

    Report Number
    9610622-2011-00474
    Event Type
    Malfunction
    Date Received
    September 23, 2011
    Date of Event
    September 8, 2011
    Report Date
    September 8, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. LOT NUMBERS ARE AS FOLLOWS: K566309, K391013, K231210.

    Description of Event or Problem · 1

    THE PHARMACIST AT THE HOSPITAL, REPORTED THAT DURING SURGERY, THE TIP OF THE DRILLS BROKE IN HALF IN THE PATIENT. ALL PIECES WERE REMOVED FROM THE PATIENT. THE SURGEON USED ANOTHER DRILL TO FINISH THE SURGERY WITHOUT DELAY. NO ADVERSE CONSEQUENCES FOR THE PATIENT OR THE USER WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL, AO, STERILE 4, 2X340 MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA K56609 K391013

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other