BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RATCHET BIPASS SUTURE PASSER

    MDR report key: 4173346 · Received October 15, 2014

    Report

    Report Number
    0001825034-2014-08151
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    August 13, 2014
    Report Date
    November 11, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HTD
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH:

    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. (B)(6). THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER CARE AND HANDLING OF INSTRUMENTS, NUMBER 1 STATES, "SURGICAL INSTRUMENTS AND INSTRUMENT CASES ARE SUSCEPTIBLE TO DAMAGE FOR A VARIETY OF REASONS INCLUDING PROLONGED USE, MISUSE, ROUGH OR IMPROPER HANDLING. CARE MUST BE TAKEN TO AVOID COMPROMISING THEIR EXACTING PERFORMANCE."

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A ROTATOR CUFF REPAIR ON (B)(6) 2014. DURING THE PROCEDURE, THE SURGEON HAD DIFFICULTY PASSING THE NITINOL WIRE. AFTER MULTIPLE ATTEMPTS THE SURGEON USED COMPETITOR PRODUCT TO COMPLETE THE PROCEDURE. THIS RESULTED IN A DELAY GREATER THAN 30 MINUTES IN THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A ROTATOR CUFF REPAIR ON (B)(6) 2014. DURING THE PROCEDURE THE SURGEON HAD DIFFICULTY PASSING THE NITINOL WIRE. AFTER MULTIPLE ATTEMPTS THE SURGEON USED COMPETITOR PRODUCT TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655870 RATCHET BIPASS SUTURE PASSER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT HTD BIOMET ORTHOPEDICS N/A 349550

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R