BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRULIANT PIN PULLER SYRINGE STYLE

    MDR report key: 12287891 · Received August 6, 2021

    Report

    Report Number
    1038671-2021-00372
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    July 16, 2021
    Report Date
    September 13, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862585882
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS D4, D9, G4, G7, H2, H3 AND H6 HAVE BEEN UPDATED ACCORDINGLY. ACCORDING TO THE INVESTIGATION, THE DEVICE HISTORY RECORDS OF THE SUBJECT DEVICES WERE REVIEWED, AND NO ISSUES WERE OBSERVED. A DESIGN REVIEW SHOWED THAT THE BREAKAGE AREA OF THE COMPONENT IS RELATIVELY THIN WHICH DOES NOT OFFER GREAT SAFETY MARGIN WHEN THE INSTRUMENT IS SUBJECT TO OFF-AXIS LOADING. ALTHOUGH THE EVALUATION COULDN¿T CONFIRM USER MIS-USE, OFF-AXIS LOADING WHICH CAN BE GENERATED BY THE USER APPLYING A BENDING MOMENT TO THE DEVICE DURING PIN DRIVING/PULLING COULD CONTRIBUTE TO THE BREAKAGE. THE BROKEN TRULIANT PIN PULLER REPORTED WAS LIKELY THE RESULT OF: 1) THE BREAKAGE AREA OF THE COMPONENT BEING RELATIVELY THIN WHICH DOES NOT OFFER GREAT SAFETY MARGIN WHEN THE INSTRUMENT IS SUBJECT TO OFF-AXIS LOADING. 2) OFF-AXIS LOADING WHEN THE USER APPLIES A BENDING MOMENT TO THE DEVICE DURING PIN DRIVING/PULLING. A RISK ASSESSMENT HAS BEEN INITIATED AND CORRECTIVE ACTIONS WERE TAKEN TO UPDATE DESIGN TO IMPROVE STRENGTH OF BREAKAGE AREA 2) UPDATE OPERATIVE TECHNIQUE TO INSTRUCT USERS TO AVOID USING THE INSTRUMENT OFF-AXIS. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1038671-2021-00372 AND 1038671-2021-00373.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1038671-2021-00373.

    Description of Event or Problem · 1

    AS REPORTED, THE PIN PULLER (CAT# 02-029-90-4100) WAS USED TO REMOVE THE PINS OUT OF THE TIBIA. THE BONE QUALITY WAS VERY GOOD AND WHEN THE SURGEON TRIED TO REMOVE THE PIN, THE TIP OF THE PIN PULLER BROKE OFF. FURTHERMORE, THE FEM IMPACTOR (02-029-19-1000) WAS BROKEN ON IMPACTION WHEN WE WERE IMPACTING THE FINAL FEMUR IMPLANT ON. ONE OF THE SIDES OF THE IMPACTOR BROKE OFF. THE SURGERY WAS NOT AFFECTED BY THE BREAKAGE. WE HAD BACKUPS AND THE CASE WENT VERY WELL. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188170 TRULIANT PIN PULLER SYRINGE STYLE PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. TRULIANT PIN PULLER SYRINGE STYLE 89895007 10885862585882

    Patients

    Seq Age Sex Outcome Treatment
    1