BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACTOSORB 14 MM RAPIDFLAP CLAMP

    MDR report key: 5772564 · Received July 6, 2016

    Report

    Report Number
    0001032347-2016-00324
    Event Type
    Malfunction
    Date Received
    July 6, 2016
    Date of Event
    April 8, 2016
    Report Date
    June 13, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK003281
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. REPORT 2 OF 2 IS REPORTED ON MFR #0001032347-2016-00325-1.

    Additional Manufacturer Narrative · 1

    UDI #: (B)(4). 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. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. REPORT 2 OF 2 IS REPORTED ON MFR #0001032347-2016-00325.

    Additional Manufacturer Narrative · 1

    (B)(4). ACCORDING TO THE PRODUCT EVALUATION, THE BROKEN CLAMPS WERE RETURNED IN BIO HAZARDOUS CONDITION, THEREFORE ONLY A VISUAL INSPECTION THROUGH THE BAG COULD BE PERFORMED. THE PRODUCT IDENTITY HAS BEEN CONFIRMED. A VISUAL EVALUATION REVEALED THAT, ON BOTH CLAMPS, THE POST HAS BROKEN RIGHT ABOVE THE OUTER PLATE; THEREFORE THE COMPLAINT IS CONFIRMED. THE MOST LIKELY UNDERLYING CAUSE OF THIS COMPLAINT WAS DETERMINED TO BE EXCESSIVE FORCE APPLIED TO THE CLAMP DURING INSERTION. BASED ON THE PRODUCT EVALUATION, FIELDS WERE UPDATED. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. REPORT 2 OF 2 IS REPORTED ON MFR #0001032347-2016-00325-2.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING A SKULL BONE FLAP FIXATION THE CLAMPS BROKE. IT WAS REPORTED THAT THERE WAS NO DELAY THAT EXCEEDED THIRTY MINUTES; THE PATIENT DID NOT RETAIN ANY FOREIGN BODY; AND THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427572 LACTOSORB 14 MM RAPIDFLAP CLAMP LACTOSORB CLAMP JEY BIOMET MICROFIXATION N/A 394870

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention