BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIBFIX BLU SYSTEM 16 HOLE PRE-BENT PLATE

    MDR report key: 6990289 · Received October 31, 2017

    Report

    Report Number
    0001032347-2017-00777
    Event Type
    Injury
    Date Received
    October 31, 2017
    Date of Event
    September 26, 2017
    Report Date
    August 6, 2018
    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE CT SCANS WERE RECEIVED AND EVALUATED. THE POTS-OP SCAN DATED (B)(6) 2017 IDENTIFIED THE RIBFIX BLU PLATES IMPLANTED LEFT SIDE RIBS 4-8 (R4-8), LATERAL SCREWS R5 MAY NOT BE FULLY SEATED AND LOCKED. POSTERIOR PLACEMENT OF PLATES ON R5-6 OFFSET SUPERIORLY COMPARED TO CENTER OF RIBS. THE POST-OP SCAN DATED (B)(6) 2017 IDENTIFIED THE R4 PLATE NOT FULLY APPROXIMATED TO RIB IN CENTER OF PLATE. THE POST-OP SCAN DATED (B)(6) 2017 IDENTIFIED THE R4 LATERAL SCREWS MAY NOT BE FULLY SEATED AND LOCKED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032447-2018-00071-1, 0001032447-2018-00072-1, AND 0001032447-2018-00073-1.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE EXPLANTED DEVICES WERE VISUALLY EVALUATED BY THE DEVELOPMENT ASSOCIATE DIRECTOR WITH A 10X LOOP AT THE HOSPITAL IN (B)(6). HE DID NOT SEE ANY VISUAL DEFECTS IN THE PLATES THAT WOULD LEAD TO PREMATURE PART FAILURE. THE HOSPITAL DOES NOT HAVE APPROVAL FROM THE PATIENT TO RETURN THE PLATES FOR FURTHER ANALYSIS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032447-2018-00071-3, 0001032447-2018-00072-3, AND 0001032447-2018-00073-3.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE REPORTS AND RADIOGRAPHS. THE PHYSICIANS REPORTS THAT WERE PROVIDED INDICATED THAT THE PATIENT HAD CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), A HISTORY OF NICOTINE ABUSE, AND A INGUINAL HERNIA. IT ALSO INDICATED PERSISTENT COUGH SYMPTOMS, PRODUCTIVE COUGH, AND RESPIRATORY THERAPY. THE MOST LIKELY UNDERLYING CAUSE OF THIS COMPLAINT IS PATIENT CONDITION. A REVIEW OF THE POST-OPERATIVE X-RAYS ALSO SUGGESTS THAT PLACEMENT AND INADEQUATE SEATING AND LOCKING OF THE SCREWS AT INITIAL IMPLANTATION MAY HAVE CONTRIBUTED TO THE LOOSENING/PLATE FRACTURE AS WELL. 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 PATIENT CONDITION AND PLACEMENT AND INADEQUATE SEATING AND LOCKING OF THE SCREWS. THE INSTRUCTION FOR USE (IFU) FOR THESE PARTS STATES IN THE SECTION TITLED WARNINGS: 7. 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: 3. MIGRATION, BENDING, FRACTURE OR LOOSENING OF THE IMPLANT. THE IFU ALSO CONTAINS A CHART AND INSTRUCTIONS FOR PROPER SCREW LENGTH SELECTION AND INSERTION TITLED BONE SCREWS AND DIRECTIONS FOR USE. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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: 0001032447-2018-00071-2, 0001032447-2018-00072-2 AND 0001032447-2018-00073-2.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: PATIENT IDENTIFIER (IN CONFIDENCE), DATE OF BIRTH, PATIENT SEX, DATE OF EVENT, DATE OF THIS REPORT, DESCRIBE EVENT OR PROBLEM, RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES, OTHER RELEVANT HISTORY, BRAND NAME, CATALOG NUMBER, IMPLANT DATE, EXPLANT DATE, CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES, (B)(4), DATE RECEIVED BY MANUFACTURER, TYPE OF REPORT AND FOLLOW-UP NUMBER, FOLLOW-UP TYPE, ADDITIONAL NARRATIVES/DATA. CONCOMITANT MEDICAL PRODUCT: BIOMET MICROFIXATION RIBFIX BLU SCREW 2.4 X 10 MM CATALOG #: 76-2410 LOT #: NI, BIOMET MICROFIXATION RIBFIX BLU SCREW 2.4 X 12 MM CATALOG #: 76-2412 LOT #: NI, BIOMET MICROFIXATION RIBFIX BLU SCREW 2.7 X 12 MM CATALOG #: 76-2712 LOT #: NI. THERAPY DATE: (B)(6) 2017. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2018-00071, 0001032347-2018-00072, AND 0001032347-2018-00073.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE PART AND LOT NUMBER ARE UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. 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.

    Description of Event or Problem · 1

    THE OPERATIVE RECORD PROVIDED INDICATED EIGHTEEN DAYS POST OPERATIVE A REVISION WAS PERFORMED OF THORAX WALL HEMATOMA AND RE-FIXATION OF PLATE (LEFT) DUE TO DISLOCATION OF THE PLATE AT C7 WITH HEMATOMA (LEFT). THE SIXTEEN HOLE PLATE AND FOUR SCREWS WERE TORN OUT OF THE SEVENTH RIB AND THERE IS CREPITUS OF THE BONE. THE ENTIRE PLATE WAS REMOVED AND A LONGER PLATE WAS NEEDED. THE RIBFIX SYSTEM WAS NOT STERILE, THEREFORE A SYNTHES PLATE AND TEN SYNTHES SCREWS WERE USED TO RE-FIXATE THE SEVENTH RIB. IT WAS REPORTED THAT MULTIPLE SCREWS WERE USED DURING THE ORIGINAL PROCEDURE. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THE SCREWS THAT WERE EXPLANTED COULD NOT BE DETERMINED BY THE OPERATIVE REPORT; THEREFORE, ALL SCREWS ARE BEING REPORTED. RECOMMENDED THERAPY: MEDICATION FOR DISMISSAL: PREDNISONE 10 MG 1-0-1 SYMBICORT TURBOHALER 2-0-2 BERODUAL SPRAY 1-1-1-1 EKLIRA SPRAY 1-0-1 PANTOZOL 40 MG 1-0-0 IBUPROFEN 600 MG 1-1-1 ACE 100 MG 1-0-0 NOVALGIN 40 GTT. IF NECESSARY AUGMENTAN 875/125 MG 1-0-1 SINCE (B)(6) 2017 TO (B)(6) 2017. IT IS REPORTED TWO ADDITIONAL REVISIONS WERE PERFORMED; THESE EVENTS ARE REPORTED ON MFR # 0001032347-2017-00778, 0001032347-2018-00070, 0001032347-2018-00074, 0001032347-2018-00075, 0001032347-2018-00076, 0001032347-2018-00077, 0001032347-2018-00078, 0001032347-2018-00079, AND 0001032347-2018-00080.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE NO COMPLICATIONS DURING THE ORIGINAL PROCEDURE OF IMPLANTATION OF PLATES FOR RIB FIXATION (5 PIECES). RE-OPERATION WAS NECESSARY AS THE PATIENT COMPLAINED ABOUT PAIN. DURING THE REOPERATION IT WAS IDENTIFIED, "FOUR SCREWS WERE TRIMMED AND FURTHER WERE LOOSENED." THE LOOSE SCREWS WERE FASTENED IN THE RE-OPERATION. THE SALES REPRESENTATIVE STATED THE SURGEON BELIEVES, "SINCE THE THREAD OF THE SCREWS IS VERY FINE, THERE WAS NOT 100% RIGHT FIXATION IS THE REASON FOR THE LOOSENING." ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769281 RIBFIX BLU SYSTEM 16 HOLE PRE-BENT PLATE RIB SCREW; SCREW, FIXATION, BONE HRS BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R