BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPASS NITINOL 10 PACK PLASTIC

    MDR report key: 3621867 · Received February 11, 2014

    Report

    Report Number
    0001825034-2014-00765
    Event Type
    Injury
    Date Received
    February 11, 2014
    Date of Event
    January 15, 2014
    Report Date
    March 17, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HXO
    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

    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 WARNINGS, NUMBER 2 STATES, " THE BIPASS SUTURE PASSER AND PUSHER WERE DESIGNED FOR USE WITH MAXBRAIDSUTURE. USE OF BIPASS INSTRUMENTS WITH SUTURE FROM OTHER MANUFACTURERS MAY COMPROMISE THE INTEGRITY OF THE INSTRUMENT AND/OR SUTURE." EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE EVALUATION, IT WAS NOTED THE NITINOL BYPASS SUTURE WAS USED WITH SUTURES FROM ANOTHER MANUFACTURER AND THEREBY THE INTEGRITY OF THE INSTRUMENT WAS COMPROMISED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A DOUBLE ROW REPAIR PROCEDURE ON (B)(6) 2014. DURING THE PROCEDURE, THE TIP OF THE BIPASS NEEDLE FRACTURED WHILE BRINGING THE THREAD THROUGH THE ROTATOR SLEEVE. THE FRACTURED TIP REMAINS IN THE PATIENT. A 45 MINUTE DELAY OCCURRED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90103 BIPASS NITINOL 10 PACK PLASTIC PUSHER, SOCKET HXO BIOMET ORTHOPEDICS N/A 369960

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R