BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSORB 1 PIN 50X1.3MM KIT

    MDR report key: 3145636 · Received June 4, 2013

    Report

    Report Number
    0001825034-2013-01819
    Event Type
    Injury
    Date Received
    June 4, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    OVZ
    PMA / PMN Number
    PK111077
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. (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 PATIENT UNDERWENT A BUNIONECTOMY ON (B)(6) 2013. DURING THE PROCEDURE, THE SURGEON WENT TO INSERT THE PIN INTO THE PATIENT AND THE PIN FRACTURED. THE PROCEDURE WAS COMPLETED WITH A NEW PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247126 ORTHOSORB 1 PIN 50X1.3MM KIT PIN, FIXATION OVZ BIOMET ORTHOPEDICS N/A 307074

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R