BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5X34MM CORT LOCK SCR STE

    MDR report key: 8227435 · Received January 8, 2019

    Report

    Report Number
    0001825034-2018-11509
    Event Type
    Injury
    Date Received
    January 8, 2019
    Date of Event
    December 14, 2018
    Report Date
    April 26, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRS
    PMA / PMN Number
    K143697
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. ONLY THE SCREW HEAD WAS RETURNED AS IT WAS RELAYED THAT THE SHAFT REMAINED IN THE PATIENT. THE SCREW IS CONFIRMED TO BE FRACTURED. THE PRODUCT WAS SUBMITTED FOR SEM ANALYSIS. THE SEM ANALYSIS SHOWED THAT THE SCREW FRACTURED DUE TO TORSIONAL OVERLOAD. MORE THAN HALF OF THE SCREW FRACTURE SHOWED A SMEARED SURFACE CAUSED BY POST FRACTURE DAMAGE. THE NON-SMEARED AREAS ON THE FRACTURE SHOWED SHEARED DUCTILE OVERLOAD DIMPLES. EDS SEMI-QUANTITATIVE ELEMENTAL ANALYSIS OF THE BONE SCREW SHOWED THAT IT WAS CONSISTENT WITH (B)(4). DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT# 856201006, ITEM NAME- DIST TIB ANTLAT LT BRD 6H STE, LOT# 974080; THERAPY DATE- (B)(6) 2018. 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. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY WITH ALPS DISTAL TIBIA PLATE, THE SCREW HEAD SHEARED OFF AND THE SHAFT OF THE SCREW WAS LEFT IN SITU WHILE INSERTING THE CORTICAL LOCKING SCREW PROXIMALLY IN THE TIBIA. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18108 3.5X34MM CORT LOCK SCR STE TRAUMA, IMPLANT HRS ZIMMER BIOMET, INC. N/A 915760

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R