BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIBFIX BLU SYSTEM SCREW, SELF-DRILLING, CANCELLOUS X-DRIVE LOCKING 2.4 X 10

    MDR report key: 7442881 · Received April 19, 2018

    Report

    Report Number
    0001032347-2018-00203
    Event Type
    Malfunction
    Date Received
    April 19, 2018
    Date of Event
    February 19, 2018
    Report Date
    September 28, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK142823
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS. VISUAL EVALUATION WAS DONE VIA THREE SETS OF CT SCANS AND X-RAYS THAT WERE PROVIDED BY THE CUSTOMER. THE SURGERY TOOK PLACE ON (B)(6) 2018. THERE WAS ONE SET OF PRE-OPERATIVE CT SCANS TAKEN ON (B)(6) 2018, ONE SET OF POST-OPERATIVE CT SCANS TAKEN ON (B)(6) 2018, AND ONE SET OF FOLLOW-UP X-RAYS TAKEN ON (B)(6) 2018. THE POST-OPERATIVE CT SCANS SHOW THE FOLLOWING: THERE WAS ONE PLATE ON THE 5TH RIB, ONE ON THE 6TH RIB, TWO ON THE 7TH RIB, ONE ON THE 8TH RIB, AND ONE ON THE 9TH RIB. THE PLATE ON THE 5TH RIB WAS A 12-HOLE PLATE, WITH 3 SCREWS FIXATED ON EACH SIDE OF THE BREAK. IT APPEARED AS THOUGH THE SCREWS ON THE LATERAL SIDE OF THE BREAK WERE NO LONGER FIXATED TO THE BONE THE PLATE ON THE 6TH RIB WAS A 16-HOLE PLATE, WITH 6 SCREWS FIXATED ON THE MEDIAL SIDE OF THE BREAK AND 4 ON THE LATERAL SIDE. IT APPEARED AS THOUGH THE SCREWS ON THE MEDIAL SIDE OF THE BREAK WERE NO LONGER FIXATED TO THE BONE. THERE ARE TWO PLATES ON THE 7TH RIB. THE FIRST WAS A 12-HOLE (TOP) PLATE, WITH 3 SCREWS ON THE MEDIAL SIDE OF THE BREAK AND 1 ON THE LATERAL SIDE. THE SECOND WAS AN 18-HOLE (BOTTOM) PLATE, WITH 4 SCREWS ON THE MEDIAL SIDE OF THE BREAK AND 4 SCREWS ON THE LATERAL SIDE. ALSO NOTED WERE 2 SCREWS THAT WERE FLOATING FREELY BETWEEN THE TWO PLATES, LIKELY FROM THE LATERAL SIDE OF THE TOP, 12-HOLE PLATE. THE PLATE ON THE 8TH RIB WAS A 16-HOLE PLATE, WITH 4 SCREWS FIXATED ON THE MEDIAL SIDE OF THE BREAK AND 5 ON THE LATERAL SIDE. THE PLATE DID NOT APPEAR TO BE PROPERLY CONTOURED TO THE CURVATURE OF THE RIB. THE PLATE ON THE 9TH RIB WAS A 16-HOLE PLATE, WITH 6 SCREWS FIXATED ON THE MEDIAL SIDE OF THE BREAK AND 5 ON THE LATERAL SIDE. THE PLATE DID NOT APPEAR TO BE PROPERLY CONTOURED TO THE CURVATURE OF THE RIB. ACROSS ALL OF THE RIBS IT APPEARED AS THOUGH THERE WAS POOR REALIGNMENT OF THE RIBS PRIOR TO THE PLATES INSTALLATION. THE FOLLOW-UP X-RAYS SHOWED THE FOLLOWING: THE TWO SCREWS THAT WERE DETACHED FROM THE TOP PLATE ON RIB 7 HAD MIGRATED FURTHER AWAY FROM THE ORIGINAL FIXATION POINTS. THE TWO PLATES FIXATED ON RIBS 8 AND 9 WERE FRACTURED. THE FRACTURE OCCURRED ON THE 8TH HOLE FROM THE MEDIAL SIDE OF THE PLATE ON EACH OF THESE RIBS, LIKELY DUE TO THE POOR ALIGNMENT OF THE RIBS PRIOR TO PLATE INSTALLATION. THE POOR ALIGNMENT CAUSED THE PLATES TO TAKE THE MAJORITY OF THE LOAD RATHER THAN SHARE THE LOAD AND PLACED ADDITIONAL STRESS IN THE MIDDLE OF THE PLATE, AT THE POINT WHERE THE RIB WAS BROKEN. THE TWO PLATES ON RIBS 8 AND 9 WERE FOUND TO BE FRACTURED AND SCREWS FROM THE PLATES ON RIBS 5, 6, AND 7 WERE FOUND TO HAVE LOST THEIR FIXATION TO THE BONE. X-RAYS AND SCANS WERE PROVIDED BY THE CUSTOMER. A REVIEW OF THE POST-OP CT SCANS AND FOLLOW-UP X-RAYS SUGGEST THAT THERE WAS POOR APPROXIMATION AND REDUCTION DURING INITIAL IMPLANTATION THAT MAY HAVE CONTRIBUTED TO THE PLATE BREAKAGE. IT IS ALSO PLAUSIBLE THAT THE CLAIM OF EXCESSIVE COUGHING MAY HAVE CAUSED SOME OF THE SCREWS TO LOSE THEIR FIXATION TO THE RIBS. THE MOST LIKELY UNDERLYING CAUSE OF THIS COMPLAINT IS DUE TO TECHNIQUE. THE INSTRUCTIONS FOR USE (IFU) FOR THESE PARTS STATES IN THE SECTION TITLED WARNINGS: INTERNAL FIXATION DEVICES AID THE SURGEON IN THE ALIGNMENT AND STABILIZATION OF BONE IN THE CHEST WALL FOR FIXATION OF FRACTURES AND RECONSTRUCTIVE PROCEDURES. WHILE THESE DEVICES ARE GENERALLY SUCCESSFUL IN ATTAINING THESE GOALS, THEY CANNOT BE EXPECTED TO REPLACE NORMAL HEALTHY BONE OR WITHSTAND THE UNSUPPORTED STRESS PLACED UPON THE DEVICE BY FULL LOAD BEARING. INTERNAL FIXATION DEVICES ARE INTERNAL SPLINTS, OR LOAD SHARING DEVICES THAT ALIGN THE FRACTURE UNTIL NORMAL HEALING OCCURS. IF THERE IS DELAYED UNION, NONUNION, OR INCOMPLETE HEALING OF BONE, THE IMPLANT CAN BE EXPECTED TO BEND, BREAK, OR FAIL. THEREFORE, IT IS IMPORTANT THAT IMMOBILIZATION OF THE FRACTURE SITE BE MAINTAINED UNTIL FIRM BONY UNION (CONFIRMED BY CLINICAL AND RADIOGRAPHIC EXAMINATION) IS ESTABLISHED. THE SIZE AND SHAPE OF BONES AND SOFT TISSUE PLACE LIMITATION ON THE SIZE AND STRENGTH OF IMPLANTS. SURGICAL IMPLANTS ARE SUBJECT TO REPEATED STRESSES IN USE, WHICH CAN RESULT IN FATIGUE FRACTURE. FACTORS SUCH AS THE PATIENT¿S ACTIVITY LEVEL, LIMITED BLOOD SUPPLY, INSUFFICIENT QUANTITY OR QUALITY OF BONE, ACTIVE OR LATENT INFECTION AND ADHERENCE TO LOAD BEARING INSTRUCTIONS MAY HAVE AN EFFECT ON THE PERFORMANCE OF THE IMPLANT. THE SURGEON MUST BE THOROUGHLY KNOWLEDGEABLE NOT ONLY IN THE MEDICAL AND SURGICAL ASPECTS OF THE IMPLANT, BUT ALSO MUST BE AWARE OF THE MECHANICAL AND METALLURGICAL ASPECTS OF THE SURGICAL IMPLANTS. ADEQUATELY INSTRUCT THE PATIENT. POSTOPERATIVE CARE IS IMPORTANT. THE PATIENT¿S ABILITY AND WILLINGNESS TO FOLLOW INSTRUCTION IS ONE OF THE MOST IMPORTANT ASPECTS OF SUCCESSFUL MANAGEMENT OF FRACTURE OR OTHER NON-UNION. PATIENTS WITH SENILITY, MENTAL ILLNESS, ALCOHOLISM, OR DRUG ABUSE MAY BE AT HIGHER RISK OF DEVICE FAILURE SINCE THESE PATIENTS MAY IGNORE INSTRUCTIONS AND ACTIVITY RESTRICTIONS. THE PATIENT IS TO BE INSTRUCTED IN THE USE OF EXTERNAL SUPPORTS AND BRACES THAT ARE INTENDED TO IMMOBILIZE THE SITE OF THE FRACTURE OR OTHER NON-UNION AND LIMIT LOAD BEARING. THE PATIENT IS TO BE MADE FULLY AWARE AND WARNED THAT THE DEVICE DOES NOT REPLACE NORMAL HEALTHY BONE, AND THAT THE DEVICE CAN BREAK, BEND OR BE DAMAGED AS A RESULT OF STRESS, ACTIVITY, LOAD BEARING OR INADEQUATE BONE HEALING. THE PATIENT IS TO BE MADE AWARE AND WARNED OF GENERAL SURGICAL RISKS, COMPLICATIONS, POSSIBLE ADVERSE EFFECTS, AND TO FOLLOW THE INSTRUCTIONS OF THE TREATING PHYSICIAN. THE PATIENT IS TO BE ADVISED OF THE NEED FOR REGULAR POSTOPERATIVE FOLLOW-UP EXAMINATION AS LONG AS THE DEVICE REMAINS IMPLANTED. THE IFU FOR THIS PRODUCT STATES IN THE SECTION TITLED POSSIBLE ADVERSE EFFECTS: MIGRATION, BENDING, FRACTURE OR LOOSENING OF THE IMPLANT. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO TECHNIQUE. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2018-00201-1, 0001032347-2018-00202-1, 0001032347-2018-00205-1, AND 0001032347-2018-00206-1.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: BIOMET MICROFIXATION RIBFIX BLU 2.7 X 10 MM EMERGENCY SCREW CATALOG #: 76-2710 LOT #: NI, BIOMET MICROFIXATION RIBFIX BLU 12 HOLE PLATE CATALOG #: 76-2602 LOT #: NI, BIOMET MICROFIXATION RIBFIX BLU 16 HOLE PLATE CATALOG #: 76-2603 LOT #: NI, BIOMET MICROFIXATION RIBFIX BLU 24 HOLE PLATE CATALOG #: 76-2604 LOT #: NI. THERAPY DATE: (B)(6) 2018. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, THE DEVICES REMAIN IMPLANTED IN THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2018-00201, 0001032347-2018-00202, 0001032347-2018-00205, AND 0001032347-2018-00206.

    Description of Event or Problem · 1

    IT WAS REPORTED TWO (MAYBE 3) PLATES CAME OUT OF THE RIBS. THERE WAS NO COMPLAINT BY THE PATIENT; THE SURGEON IDENTIFIED THE LOOSENING OF THE PLATES ON THE POST-OP CT- SCAN ELEVEN DAYS AFTER THE PROCEDURE. DURING THE CASE THE PRODUCT LOOKED TO PERFORM WELL AND WAS CENTERED ONTO THE RIB. HOWEVER, FOLLOWING THE OPERATION, SEVERAL OF THE PLATES DETACHED FROM THE RIBS. UPON REVIEW OF THE POST-OP SCANS THE SCREWS DO NOT LOOK TO BE INTO THE ACTUAL RIBS. THE PATIENT WAS VERY LARGE AND HE WAS COUGHING POST SURGERY WHICH MAY HAVE BEEN PART OF THE ISSUE AND PERHAPS THEY DETACHED DURING ONE OF THE COUGHING SPELLS. THE PATIENT BROKE HIS RIBS BY COUGHING; THIS HAPPENED TWO TIMES. ALSO THE RIBS CAME LOOSE FROM THE CARTILAGE BY COUGHING. UPON FOLLOW-UP IT WAS REPORTED TWO OF THE 16 HOLE PLATES ARE BROKEN. THIS WAS ASSESSED AFTER OPERATION BY EXAMINING THE RESECTED RIB PARTS. THE PATIENT SUFFERS FROM PAIN RIGHT NOW. PAIN IS NOT DUE TO THE BROKEN PLATE. THE SURGEON HAS NOT PLANNED TO RE-OPERATE AT THIS TIME AS HE DOESN¿T WANT TO COMPROMISE THE BONE HEALING IN THE RIBS WHICH ARE GOOD ALIGNED NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285084 RIBFIX BLU SYSTEM SCREW, SELF-DRILLING, CANCELLOUS X-DRIVE LOCKING 2.4 X 10 BONE SCREW HRS BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR