BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0MM TI W/ MAXBRAID SUTURE

    MDR report key: 2772653 · Received October 4, 2012

    Report

    Report Number
    0001825034-2012-01838
    Event Type
    Injury
    Date Received
    October 4, 2012
    Date of Event
    July 26, 2012
    Report Date
    September 6, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HWC
    PMA / PMN Number
    PK080088
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN. MANUFACTURE DATE - UNKNOWN. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER PRECAUTION, STATES: "INTRAOPERATIVE FRACTURE OR BREAKING OF INSTRUMENTS HAS BEEN REPORTED. 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 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01836/01838).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY PRODUCT IDENTIFICATION AND PRODUCT EVALUATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. EVALUATION OF DEVICE FOUND EVIDENCE THAT FAILURE MODE WAS DUE TO IMPROPER BONE PREPARATION AND/OR EXCESSIVE TORQUE ON THE IMPLANT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, NUMBER 8 STATES, "DO NOT USE EXCESSIVE FORCE WHEN INSERTING SUTURE ANCHORS. EXCESSIVE FORCE (E.G. LONG HARD HAMMER BLOWS) MAY CAUSE FRACTURE OR BENDING OF THE DEVICE. PRIOR TO INSERTION OF THE IMPLANT, PREDRILL, AWL OR TAP." THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01836-1 / 01838-1).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A BANKART SUTURE SHOULDER PROCEDURE ON (B)(6) 2012. DURING THE PROCEDURE, THE BASE OF THE ANCHOR FRACTURED IN THE SHAFT, CAUSING PATIENT TO RETAIN A FOREIGN BODY AND RESULTING IN A DELAY GREATER THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.0MM TI W/ MAXBRAID SUTURE SCREW, FIXATION, BONE HWC BIOMET ORTHOPEDICS N/A 822280

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R