BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOSORB 1 PIN 50X1.3MM KIT

    MDR report key: 3579727 · Received January 16, 2014

    Report

    Report Number
    0001825034-2014-00434
    Event Type
    Malfunction
    Date Received
    January 16, 2014
    Date of Event
    December 6, 2013
    Report Date
    March 24, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    OVZ
    PMA / PMN Number
    PK111077
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. DEVICE AVAILABILITY - THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS. (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.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. EVALUATION OF DEVICE FOUND EVIDENCE THAT FAILURE MODE WAS LIKELY DUE TO MISUSE BY IMPLANT BEING PUT THROUGH EXCESSIVE FORCE OR OVER TORQUED, AND/OR NOT INSPECTED FOR WEAR AND DISFIGUREMENT WHICH MAY HAVE PREVENTED THE USE OF THE IMPLANT AND ITS FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A BUNNIONECTOMY UTILIZING A PIN ON (B)(6) 2013. DURING THE PROCEDURE, THE PIN FRACTURED UPON INSERTION. ANOTHER PIN WAS UTILIZED TO COMPLETE THE PROCEDURE WITH NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42755 ORTHOSORB 1 PIN 50X1.3MM KIT PIN, FIXATION OVZ BIOMET ORTHOPEDICS N/A 326136

    Patients

    Seq Age Sex Outcome Treatment
    1