BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LACTOSORB SYSTEM 14 MM RAPID FLAP CLAMP

    MDR report key: 5614799 · Received April 28, 2016

    Report

    Report Number
    0001032347-2016-00206
    Event Type
    Injury
    Date Received
    April 28, 2016
    Date of Event
    February 24, 2016
    Report Date
    March 31, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK003281
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION. BASED ON THE EVALUATION, THE COMPLAINT WAS CONFIRMED AS THE RAPID FLAP CLAMPS WERE FOUND TO HAVE BEEN BROKEN DURING SURGERY. THE MOST-LIKELY, UNDERLYING CAUSE WAS DETERMINED TO BE EXCESSIVE FORCE APPLIED TO THE CLAMP DURING INSERTION. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS IS SUPPLEMENTAL REPORT 1 OF 3 FOR THE SAME EVENT. SUPPLEMENTAL REPORTS 2 AND 3 ARE REPORTED ON MFR # 0001032347-2016-00207-2 AND 0001032347-2016-00208-2.

    Additional Manufacturer Narrative · 1

    THIS IS SUPPLEMENTAL REPORT 1 OF 3 FOR THE SAME EVENT. SUPPLEMENTAL REPORTS 2 AND 3 ARE REPORTED ON MFR ##0001032347-2016-00207-1 AND 0001032347-2016-00208-1.

    Additional Manufacturer Narrative · 1

    THIS LOT CONTAINED ONE (1) OF THE 4 CLAMPS IN QUESTION. THIS IS A RESORB-ABLE PRODUCT; THEREFORE, PERMANENT IMPAIRMENT IS NOT EXPECTED TO OCCUR FROM REMAINING IMPLANTED IN THE PATIENT. REVIEW OF THE DEVICE HISTORY RECORDS SHOW THAT THE LOT WAS RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. THE PRODUCT WAS IMPLANTED INTO THE PATIENT AND THEREFORE WILL NOT BE RETURNED FOR AN EVALUATION. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. (B)(4). THIS IS REPORT 1 OF THREE (3) FOR THE SAME EVENT. REPORTS 2-3 ARE REPORTED ON MFR #0001032347-2016-00207 AND 0001032347-2016-00208.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR (4) LACTOSORB RAPIDFLAP CLAMPS BROKE DURING SURGERY. THE PARTS REMAIN IN THE PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269400 LACTOSORB SYSTEM 14 MM RAPID FLAP CLAMP LACTOSORB CLAMP JEY BIOMET MICROFIXATION N/A 918490

    Patients

    Seq Age Sex Outcome Treatment
    1 Other