BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET MICROFIXATION THORACIC FIXATION SYSTEM

    MDR report key: 6392422 · Received March 9, 2017

    Report

    Report Number
    0001032347-2017-00174
    Event Type
    Injury
    Date Received
    March 9, 2017
    Report Date
    March 13, 2017
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK142823
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 NOT RETURNED BY THE HOSPITAL FOR AN EVALUATION. BECAUSE THE LOT NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORDS COULD NOT BE PULLED AND REVIEWED. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE PLATE PART NUMBER IS UNKNOWN, IF THE PRODUCT INFORMATION IS IDENTIFIED A MEDWATCH WILL BE SUBMITTED. 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.

    Additional Manufacturer Narrative · 1

    LOT #: POTENTIAL LOT NUMBERS HAVE BEEN IDENTIFIED: J094190, J103470, J154290. THE DEVICE HISTORY RECORDS FOR THESE LOTS HAVE BEEN REVIEWED AND NO NON-CONFORMANCES WERE IDENTIFIED. LOT J094190, MANUFACTURE DATE NOV. 3, 2016, (B)(4). LOT J103470, MANUFACTURE DATE NOV. 4, 2016, (B)(4). LOT J154290, MANUFACTURE DATE FEB. 19, 2016, (B)(4). THIS IS SUPPLEMENTAL REPORT ONE OF TWO FOR THE SAME EVENT, REFERENCE REPORT 0001032347-2017-00405-1.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING THE ORIGINAL SURGERY, TWO RIBFIX PLATES AND AT LEAST THREE SCREWS ON EACH SIDE OF THE FRACTURE WERE IMPLANTED INTO THE PATIENT. X-RAYS REVEALED THE SCREWS HAD LOOSENED FROM THE PLATE, MIGRATED IN THE PATIENT'S BODY. A REVISION TOOK PLACE TO REMOVE THE PLATES AND SCREWS FROM THE THORAX. ONE RIB WAS FIXED WITH MEDXPERT STRACOS AND THE SECOND RIB WAS FIXED WITH RIBFIX BLU SYSTEM AGAIN. IT IS STATED THAT, SINCE THE SCREWS' LOCKING MECHANISMS WERE ENGAGED CORRECTLY, THE CAUSE FOR THE LOOSENING IS UNKNOWN. IT IS REPORTED THE SURGICAL TECHNIQUE WAS FOLLOWED. THE SURGEON USED A POWER DRIVER TO INSERT THE SCREWS AND A MANUAL DRIVER TO LOCK THEM INTO THE PLATES. THE SURGEON CHOSE THE SCREW LENGTH USING A LENGTH GAUGE ACCORDING TO SPECIFICATIONS; THUS, A BI-CORTICAL FIXATION WAS ACHIEVED. THE REASON FOR THE REVISION WAS STATED AS: DISLOCATION AND LOOSENING.

    Description of Event or Problem · 1

    (IN ADDITION TO WHAT WAS ALREADY REPORTED). ACCORDING TO THE SALES REPRESENTATIVE, "NEW SCREWS WERE USED (EMERGENCY SCREWS) AND THE LOOSENED SCREWS WERE REMOVED FROM THE BODY. THIS MEANS THAT THE PRIMARY PLATES ARE STILL IN THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175888 BIOMET MICROFIXATION THORACIC FIXATION SYSTEM RIBFIX BLU SCREW SELF-DRILLING LOCKING 2.4 X 8 MM HRS BIOMET MICROFIXATION N/A SEE H10 NARRATIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R