BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAUMAONE SYSTEM 2.0X6MM CROSS-DRIVE SCREW

    MDR report key: 7638291 · Received June 26, 2018

    Report

    Report Number
    0001032347-2018-00396
    Event Type
    Injury
    Date Received
    June 26, 2018
    Date of Event
    May 15, 2018
    Report Date
    March 5, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK081067
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE PLATE 4 HOLE STRAIGHT W/GAP 1.0MM (PART# 42-1004, LOT# 149020), PLATE 4 HOLE STRAIGHT 1.0MM (PART# SP-2284, LOT# 572730), TWO (2) SCREWS 2.0X6MM CROSS-DRIVE (PART# 41-2006, LOT# 286760), FOUR (4) SCREWS 2.0X6MM X-DRIVE LOCKING (PART# 41-2106, LOT# 979570), SCREW 2.3X5MM CROSS-DRIVE (PART# 41-2305, LOT# 031410), SCREW 2.0X5MM CROSS DRIVE (PART# 41-2005, LOT# 484740) WERE EXPLANTED AND RETURNED FOR EVALUATION. ALL PARTS SHOWED SIGNS OF USE, AS BOTH PLATES WERE FRACTURED ACROSS THE FULL OUTER DIAMETER OF ONE OF THE SCREW HOLES AND THE SCREWS SHOWED WEAR ON THE THREADS. THE ORIGINAL IMPLANT WAS A SAGITTAL SPLIT RAMAL OSTEOTOMY ON (B)(6) 2018, THE DATE THE ALLEGED EVENT OCCURRED WAS (B)(6) 2018, AND THE DATE OF REMOVAL WAS (B)(6) 2018. THE ACTUAL TIMEFRAME OF THIS EVENT WAS THEREFORE ABOUT 3.5 MONTHS, RATHER THAN THE 1.5 MONTHS STATED IN THE COMPLAINT. LIMITED INFORMATION WAS PROVIDED, AND NO SCANS, XRAYS, OR PHYSICIAN'S REPORTS WERE PROVIDED. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT IS MATERIAL FATIGUE. THE FATIGUE MAY HAVE BEEN A RESULT OF NOT SELECTING THE OPTIMAL PLATE. THESE PLATES WERE LIKELY TOO THIN FOR THIS APPLICATION. THE INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT HAS THE FOLLOWING INFORMATION IN THE SECTION TITLED WARNINGS: 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, AND ADHERENCE TO LOAD BEARING INSTRUCTIONS HAVE AN EFFECT ON THE SERVICE LIFE 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. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO MATERIAL FATIGUE. 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2018-00394-2, 0001032347-2018-00395-2, 0001032347-2018-00397-2, 0001032347-2018-00398-2, AND 0001032347-2018-00399-2.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF PHOTOGRAPHS. FUNCTIONAL TESTING AND INSPECTIONS COULD NOT BE PERFORMED DUE TO THE PRODUCTS NOT BEING RETURNED. HOWEVER, A PHOTOGRAPH WAS PROVIDED THAT SHOWS THE SCREWS APPEAR TO BE INTACT, BUT THE TWO (2) EXPLANTED PLATES ARE FRACTURED. LIMITED INFORMATION WAS PROVIDED, AND NO SCANS, X-RAYS, OR PHYSICIAN'S REPORTS WERE PROVIDED. DEVICE HISTORY RECORDS (DHR'S) WERE REVIEWED AND NO DISCREPANCIES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THE INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT HAS THE FOLLOWING INFORMATION UNDER POSSIBLE ADVERSE EFFECTS AND COMPLICATIONS: POOR BONE FORMATION, OSTEOPOROSIS, OSTEOLYSIS, OSTEOMYELITIS, INHIBITED REVASCULARIZATION, OR INFECTION CAN CAUSE LOOSENING, BENDING, CRACKING OR FRACTURE OF THE DEVICE. MANDIBULAR DEVICES CAN FRACTURE, BEND, BREAK OR FAIL IF USED TO BRIDGE A MANDIBULAR RESECTION SITE, IN THE ABSENCE OF A GRAFT. ALSO, IN THE SECTION TITLED BONE PLATES: BONE PLATES MAY NEED TO BE CONTOURED TO THE SURFACE OF THE BONE BY BENDING THE PLATES WITH A BENDING INSTRUMENT. CARE MUST BE TAKEN TO ACHIEVE THE APPROPRIATE CONTOUR WITH AS FEW BENDS AS POSSIBLE. REPEATED BENDING OF TITANIUM INCREASES THE RISK OF FRACTURE. SHARP ANGLES AND SMALL BENDING RADII MUST BE AVOIDED TO REDUCE THE RISK OF THE DEVICE BREAKING. 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: 0001032347-2018-00394-1, 0001032347-2018-00395-1, 0001032347-2018-00397-1, 0001032347-2018-00398-1, AND 0001032347-2018-00399-1.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: BIOMET MICROFIXATION TRAUMAONE SYSTEM 4 HOLE STRAIGHT W/GAP 1.0 MM PLATE CATALOG #: 42-1004 LOT #: 149020, BIOMET MICROFIXATION TRAUMAONE SYSTEM 4 HOLE STRAIGHT PLATE, 1.0 MM CATALOG #: SP-2284 LOT #: 572730, BIOMET MICROFIXATION TRAUMAONE SYSTEM 2.0 X 6 MM CROSS-DRIVE LOCKING SCREW CATALOG #: 41-2106 LOT #: 979570, BIOMET MICROFIXATION TRAUMAONE SYSTEM 2.3 X 5 MM CROSS-DRIVE SCREW CATALOG #: 41-2305 LOT #: 031410, BIOMET MICROFIXATION TRAUMAONE SYSTEM 2.0 X 5 MM CROSS-DRIVE SCREW CATALOG #: 41-2005 LOT #: 484740. THERAPY DATE: (B)(6) 2018. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001032347-2018-00394, 0001032347-2018-00395, 0001032347-2018-00397, 0001032347-2018-00398, AND 0001032347-2018-00399.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A REVISION DUE TO IMPLANT FRACTURE. THE ORIGINAL PROCEDURE WAS A SAGITTAL SPLIT RAMAL OSTEOTOMY. THE PLATE BROKE ONE AND A HALF MONTHS AFTER THE ORIGINAL PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481828 TRAUMAONE SYSTEM 2.0X6MM CROSS-DRIVE SCREW BONE SCREW JEY BIOMET MICROFIXATION N/A 286760

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R