BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI-LOCKING SCREW, SYS3.5, HEX, 18MM

    MDR report key: 7755532 · Received August 7, 2018

    Report

    Report Number
    0009613350-2018-00739
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    April 23, 2018
    Report Date
    October 29, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    PMA / PMN Number
    PN/A
    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 · 0

    D11 CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: MEDICAL PRODUCT: TI-PLATE RIGHT, SYS2.7/3.5, ITEM# 28.15.005, LOT# 14432 THERAPY DATE: APR 23, 2018. MEDICAL PRODUCT: TI-LOCKING SCREW, SYS3.5, HEX, 16MM, ITEM# 28.20.016, LOT# UNKNOWN THERAPY DATE: APR 23, 2018. MEDICAL PRODUCT: TI-LOCKING SCREW, SYS2.7, TX8, 12MM, ITEM# 28.25.012, LOT# UNKNOWN THERAPY DATE: APR 23, 2018. MEDICAL PRODUCT: TI-LOCKING SCREW, SYS2.7, TX8, 14MM, ITEM# 28.25.014, LOT# UNKNOWN THERAPY DATE: APR 23, 2018. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS FOR THE PLATE INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THE DHR CHECK FOR THE SCREWS COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: SCREWS DISENGAGE FROM PLATE. EVENT SUMMARY: IT WAS REPORTED THAT THE SCREWS WERE LOOSENED FROM THE THREADS OF THE DOCPRICE REVISION PLATE. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS: VISUAL EXAMINATION: THE DOCPRICE PLATE, TWO 2.7MM SCREWS AND FOUR 3.5MM SCREWS HAVE BEEN RETURNED FOR AN INVESTIATION. THE PLATE AS WELL AS THE SCREWS STILL SEEM TO BE FUNCTIONAL. THERE ARE SOME SCRATCHES ON THE PLATE, WHICH MIGHT HAVE ORIGINATED DURING EXPLANTATION. NO OTHER CONSPICUOUSSNESS FOUND. REVIEW OF PRODUCT DOCUMENTATION SURGICAL TECHNIQUE: THE SURGICAL TECHNIQUE DESCRIBED THE IMPLANTATION TECHIQUE OF THE PLATE AND THE SCREWS. PRODUCT DRAWING: THE PRODUCT DRAWING FOR THE PLATE VALID AT THE TIME OF MANUFACTURING HAS BEEN REVIEWED. THE THREADS HAS BEEN MARKED TO BE AN INSPECTION CHARACTERISTIC. THE DHR INDICATED THAT 20 OF THE 94 PARTS HAVE BEEN INSPECTED AND NO FAILURE HAS BEEN FOUND. ROOT CAUSE ANALYSIS ROOT CAUSE DETERMINATION USING RMW: IMPLANT LOOSENING, NON-UNION DUE TO INSUFFICIENT STABILITY OF PLATE-SCREW COMPLEX => POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. MALFUNCTION, INSUFFICIENT DEVICE PERFORMANCE OR DURABILITY DUE TO 1) USER´S DISREGARD OF MANUFACTURER´S RECOMMENDATION 2) USE ERROR (SLIPS, LAPSES, MISTAKES, REASONABLY FORESEEABLE MISUSE) 3) ABNORMAL USE BEYOND RISK CONTROL => POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. CONCLUSION SUMMARY: IT WAS REPORTED THAT AFTER ONE YEAR IN VIVO, THE SCREWS DISENGAGED FROM THE PLATE. NEITHER X-RAYS, OPERATIVE NOTES NOR OFFICE VISIT NOTES WERE RECEIVED; THEREFORE ANY CONTRIBUTING FACTORS TO THIS EVENT REMAIN UNKNOWN. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. AS NO X-RAYS ARE AVAILABLE, THE IMPLANT POSITION REMAINS UNKNOWN. MOREOVER, THE REPORTED EVENT CANNOT BE CONFIRMED. NO ADDITIONAL EVENTS HAVE BEEN REPORTED FOR THE PART NUMBER OF THE PLATE. THE QUALITY DOCUMENTATION OF THE PLATE CONFIRM THAT IT HAS BEEN MANUFACTURED ACCORDING TO SPECIFICATIONS. THERE IS NO INDICATION FOR A PRODUCT FAILURE. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED EVENT. THEREFORE, AN EXACT ROOT CAUSE CANNOT BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2018-00737, 0009613350-2018-00738, 0009613350-2018-01100, 0009613350-2018-01101.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY ONE YEAR POST IMPLANTATION A PATIENT UNDERWENT REVISION SURGERY DUE TO LOOSENING OF THE IMPLANT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: DOCPRICE, REVISION TI-PLATE, RIGHT (B)(4), CATALOG #: 28.15.005, LOT #: 14432; UNKNOWN SCREW TRAUMA IMPL. THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. (B)(4). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350 - 2018 - 00737, 0009613350 - 2018 - 00738.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH UNKNOWN SCREW. SUBSEQUENTLY, APPROXIMATELY ONE YEAR POST IMPLANTATION THE PATIENT UNDERWENT REVISION SURGERY DUE TO LOOSENING OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600763 TI-LOCKING SCREW, SYS3.5, HEX, 18MM RECON SYSTEM HRS ZIMMER GMBH N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R