BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.2MM X 460MM COCR THD TIP

    MDR report key: 3090098 · Received May 2, 2013

    Report

    Report Number
    0001825034-2013-01237
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 4, 2013
    Manufacturer
    BIOMET TRAUMA
    Product Code
    HTY
    PMA / PMN Number
    PK831005
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER PRECAUTIONS IT STATES, "SURGICAL INSTRUMENTS ARE SUBJECT TO WEAR WITH NORMAL USAGE. INSTRUMENTS, WHICH HAVE EXPERIENCED EXTENSIVE USE OR EXCESSIVE FORCE, ARE SUSCEPTIBLE TO FRACTURE." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01237 / 01238). 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.

    Additional Manufacturer Narrative · 1

    PRODUCT IS NOT AVAILABLE FOR RETURN. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01237 / 01238).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE OF COMPETITOR PRODUCTS ON (B)(6) 2013 DUE TO NON-UNION. DURING THE PROCEDURE, THE SURGEON WAS INSERTING THE PHOENIX NAIL INTO THE PATIENT WITH A SLAP HAMMER WHEN THE HANDLE FRACTURED. NO PIECES OF THE HANDLE FELL INTO THE PATIENT'S WOUND. THE SURGEON THEN HAD DIFFICULTY INSERTING THE 3.2 X 460 PIN THROUGH THE NAIL AND THE TIP OF THE PIN FRACTURED AND WAS RETAINED BY THE PATIENT. THE SURGEON WAS ABLE TO SUCCESSFULLY IMPLANT A 3.2 X 560 PIN. THE SURGEON THEN HAD DIFFICULTY DRILLING THE SUPERIOR HOLE AND WHEN INSERTING THE SCREW THE FLUOROSCOPY SHOWED THE TIP OF THE DRILL BIT IN THE FEMORAL HEAD. AS A RESULT, THE DRILL BIT REMAINED IN THE PATIENT AND THE SURGEON USED A SMALLER SCREW. WHILE TAPPING THE END OF THE INSERTER CONNECTOR WITH A MALLET TO INSERT THE SCREW, THE INSERTER CONNECTOR FRACTURED. NO PIECES OF THE INSERTER CONNECTOR FELL INTO THE PATIENT'S WOUND. AS A RESULT, THERE WAS A DELAY GREATER THAN 30 MINUTES TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191562 3.2MM X 460MM COCR THD TIP PIN, FIXATION HTY BIOMET TRAUMA N/A 427430

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S