BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A/R SCREW DRILL

    MDR report key: 3597375 · Received January 29, 2014

    Report

    Report Number
    0001825034-2014-00552
    Event Type
    Injury
    Date Received
    January 29, 2014
    Date of Event
    January 13, 2014
    Report Date
    January 13, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HTW
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE & LOT NUMBER - UNKNOWN. MANUFACTURE DATE ¿ UNKNOWN. (NOTE: BIOMET, INC. ACQUIRED THE TRAUMA PRODUCT LINE FROM DEPUY ORTHOPAEDICS, INC. (¿DEPUY¿) ON JUNE 16, 2012 (¿CLOSING DATE¿). PURSUANT TO THE WRITTEN AGREEMENT BETWEEN BIOMET AND DEPUY, BIOMET AGREED TO BE RESPONSIBLE FOR REGULATORY REPORTING FOR EVENTS WHICH OCCURRED AFTER THE CLOSING DATE REGARDLESS OF THE ENTITY THAT ACTUALLY MANUFACTURED THE PRODUCT OR ACTUALLY SOLD THE PRODUCT TO THE HEALTHCARE PROVIDER. BECAUSE THE PRODUCT THAT IS THE SUBJECT MATTER WAS MANUFACTURED BEFORE THE CLOSING DATE, PLEASE BE ADVISED THAT THE SUBJECT PRODUCT WAS MANUFACTURED BY DEPUY AND NOT BIOMET.) DEPUY ALSO SOLD THE PRODUCT THAT IS THE SUBJECT MATTER TO THE HEALTHCARE PROVIDER INVOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A PROPHYLATIC NAILING PROCEDURE ON (B)(6) 2014. DURING THE PROCEDURE, THE TIP OF THE DRILL FRACTURED AGAINST THE NAIL. THE FRACTURED TIP REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63412 A/R SCREW DRILL BIT, DRILL HTW BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention