BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREWDRIVER

    MDR report key: 2907217 · Received January 10, 2013

    Report

    Report Number
    0001825034-2013-00089
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    November 26, 2012
    Report Date
    December 21, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HXX
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN. MANUFACTURE DATE - UNKNOWN. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-002615-1 & 2013-00089).

    Additional Manufacturer Narrative · 1

    DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION.THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02615-2 /2013- 00089-1).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A SHOULDER ARTHROPLASTY ON (B)(6) 2012. DURING THE PROCEDURE, IT WAS NOTED THE CUSTOM JIG DID NOT MATCH THE PICTURE PROVIDED AND THE SCREW DRIVER REQUESTED WAS NOT THE CORRECT SIZE TO TIGHTEN THE SMALL SCREWS. THE JIG NEEDED TO BE MANUALLY ALIGNED RESULTING IN A DELAY OVER 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15027 SCREWDRIVER SCREWDRIVER, INSTRUMENT HXX BIOMET ORTHOPEDICS N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R