BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7 MM LOCKING SCREW 18 MM LENGTH

    MDR report key: 7588835 · Received June 11, 2018

    Report

    Report Number
    0001822565-2018-03172
    Event Type
    Injury
    Date Received
    June 11, 2018
    Date of Event
    April 16, 2018
    Report Date
    November 4, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWC
    PMA / PMN Number
    PK070906
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS NO DEVICE WAS RETURNED. DEVICE HISTORY RECORD (DHR) REVIEW IDENTIFIED NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. ROOT CAUSE IS UNKNOWN. A BATCH EXAMINATION OF DEVICES WITH RELATED ISSUES WAS PERFORMED. FOLLOWING THE REMOVAL OF CONTAMINATION ON THE DEVICES, SCANNING ELECTRON MICROSCOPY IDENTIFIED ISOLATED PITTING CORROSION AT THE SCREW PLATE INTERFACE CONSTRAINED TO THE LOCKING THREADS OF THE PLATE AND THE SCREWS. THE ISOLATED PITTING WAS NOT IDENTIFIED IN OTHER LOCATIONS OF THE LOCKING PLATES AND SCREWS, INCLUDING THE DISCOLORED AREAS SURROUNDING THE HOLES FROM WHICH THE TISSUE DEPOSITS WERE REMOVED. REVIEW OF THE RELATED ISSUE COMPLAINT DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE ANALYSIS CONFIRMS THE DEVICE AND IT¿S MATERIALS ARE CONFORMING TO SPECIFICATIONS. ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME. THE DEVICE LABELING STATES THAT IN-VIVO IMPLANT CORROSION IS A POSSIBLE ADVERSE EFFECT THAT MAY BE ANTICIPATED AS THE DEVICE IS IMPLANTED IN A CORROSIVE ENVIRONMENT. OCCURRENCE RATES ARE WITHIN THE EXPECTED RATES THEREFORE; NO FURTHER ACTION IS NEEDED AT THIS TIME. 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.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORTING.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 47234801635, PERIARTICULAR SCREWS STERILE, 63486170, 47234801635, PERIARTICULAR SCREWS STERILE, 63085306, 47482801602, 2.7MM UNIV LOCKING SCRS ST, 63416587, 47482801202, 2.7MM UNIV LOCKING SCRS ST, 63585778, 47482801802, 2.7MM UNIV LOCKING SCREWS, 63500426, 47234801635, PERIARTICULAR SCREWS STERILE, 63486170, 47482802002, 2.7MM UNIV LOCKING SCREWS, 62602704, 47234801435, PERIARTICULAR SCREWS, 63486167, 47235701706, PERIARTICULAR LKNG PLT FIB ST, 63202116. REPORT SOURCE, FOREIGN - THE EVENT OCCURRED IN THE (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: 0001822565 - 2018 - 03168, 0001822565 - 2018 - 03169, 0001822565 - 2018 - 03170, 0001822565 - 2018 - 03171, 0001822565 - 2018 - 03167, 0001822565 - 2018 - 03173, 0001822565 - 2018 - 03174, 0001822565 - 2018 - 03175, 0001822565 - 2018 - 02639.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. EVENT DATE - (B)(6)2017. UDI (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF A PICTURE OF THE DEVICE. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A PICTURE OF THE PLATE IS PROVIDED. DISCOLORATION IS SEEN ON THE LATE. HOWEVER, WITHOUT THE PRODUCT, NO FURTHER EVALUATIONS CAN BE PERFORMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: MEDICAL PRODUCTS - 2.0 MM CANNULA D-DRIVE FOR USE WITH 3.5 MM / 2.7 MM LOCKING SCREW, CATALOG #: 00236002120 LOT #: 61235788 QTY: 4.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S TRAUMA PLATE WAS REVISED DUE TO REDNESS, SOFT TISSUE IRRITATION, PAIN, INFECTION, AND SWELLING. UPON EXPLANTATION, IT WAS NOTED THAT THERE WAS CORROSION AND DISCOLORATION ON THE PLATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S TRAUMA PLATE WAS REVISED DUE TO REDNESS, SOFT TISSUE IRRITATION, PAIN, INFECTION, AND SWELLING. UPON EXPLANTATION, IT WAS NOTED THAT THERE WAS CORROSION AND DISCOLORATION ON THE PLATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429641 2.7 MM LOCKING SCREW 18 MM LENGTH SCREW, FIXATION HWC ZIMMER BIOMET, INC. N/A 63500426

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R