BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALCANEAL COMPRESSION SCREW, RIGHT A3 NAIL M10 X 10MM

    MDR report key: 5320112 · Received December 22, 2015

    Report

    Report Number
    0008031020-2015-00625
    Event Type
    Malfunction
    Date Received
    December 22, 2015
    Date of Event
    June 2, 2014
    Report Date
    June 3, 2014
    Manufacturer
    STRYKER GMBH
    Product Code
    HSB
    PMA / PMN Number
    K130147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING DATE WAS ADDED.

    Additional Manufacturer Narrative · 1

    WITH GUIDANCE FROM THE MDR POLICY BRANCH OF THE FDA, MDR REPORTED BY STRYKER (B)(4) AS A RESULT OF A RETROSPECTIVE LOOKBACK OF COMPLAINTS RESULTING FROM THE ACQUISITION OF ASSETS FROM SMALL BONE INNOVATION, INC. (B)(4). DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. THE DEVICE IS NOT AVAILABLE TO STRYKER.

    Description of Event or Problem · 1

    LEFT/RIGHT COMPRESSION SCREWS WERE LABELED (LASER ETCHED) INCORRECTLY. THE LEFT SCREWS FIT INTO RIGHT NAILS AND THE RIGHT SCREWS FIT INTO LEFT NAILS. COMPRESSION SCREWS FOR LOT 1331001 FOR PART NUMBERS 933-0033 AND 933-0034 WERE CONFIRMED TO BE ASSEMBLED INCORRECTLY. THIS LOT OF PARTS FOR BOTH PART NUMBERS WAS REWORKED, RESTORING PARTS TO THEIR INTENDED CONFIGURATION OF LEFT HAND AND RIGHT HAND.

    Description of Event or Problem · 1

    LEFT/RIGHT COMPRESSION SCREWS WERE LABELED (LASER ETCHED) INCORRECTLY. THE LEFT SCREWS FIT INTO RIGHT NAILS AND THE RIGHT SCREWS FIT INTO LEFT NAILS. COMPRESSION SCREWS FOR LOT 1331001 FOR PART NUMBERS 933-0033 AND 933-0034 WERE CONFIRMED TO BE ASSEMBLED INCORRECTLY. THIS LOT OF PARTS FOR BOTH PART NUMBERS WAS REWORKED, RESTORING PARTS TO THEIR INTENDED CONFIGURATION OF LEFT HAND AND RIGHT HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845737 CALCANEAL COMPRESSION SCREW, RIGHT A3 NAIL M10 X 10MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER GMBH 1331001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other