BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL BIT WITH QUICK COUPLING, 2-FLUTED, ø 2.5 MM, 154/180 MM

    MDR report key: 19829006 · Received July 25, 2024

    Report

    Report Number
    0009613350-2024-00308
    Event Type
    Injury
    Date Received
    July 25, 2024
    Date of Event
    July 1, 2024
    Report Date
    December 5, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRX
    UDI-DI
    00889024298064
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10. PRODUCT INFORMATION WAS PROVIDED FOR THE FOLLOWING SCREWS; HOWEVER, IT IS UNKNOWN WHICH ONE INTERFERED WITH THE DRILL BIT: NCB SCREW 5.0 L = 16, ITEM #: 02.02150.016, LOT #: 3054220 QTY:1. NCB SCREW 5.0 L = 30, ITEM #: 02.02150.030, LOT #: 3169138 QTY:1. NCB SCREW 5.0 L = 32, ITEM #: 02.02150.032, LOT #: 3158637 QTY:1. NCB SCREW 5.0 L = 36, ITEM #: 02.02150.036, LOT #: 3169095 QTY:1. NCB SCREW 5.0 L = 46, ITEM #: 02.02150.046, LOT #: 3172390 QTY:1. NCB SCREW 5.0 L = 55, ITEM #: 02.02150.055, LOT #: 3169900 QTY:1. NCB CLAMP-SCREW, ITEM #: 02.02150.300, LOT #: 3174954, QTY:2. NCB CLAMP-SCREW, ITEM #: 02.02150.300, LOT #: 3186326, QTY:2. NCB CLAMP-SCREW, ITEM #: 02.02150.300, LOT #: 3186328, QTY:1. NCB CLAMP-SCREW, ITEM #: 02.02150.300, LOT #: 3187098, QTY:1. NCB CLAMP-SCREW, ITEM #: 02.02150.300, LOT #: 3191501, QTY:3. NCB CLAMP-SCREW, ITEM #: 02.02150.300, LOT #: 3191502, QTY:2. NCB CANC SCREW 5.0 32MM L80, ITEM #: 02.02152.080, LOT #: 3160683, QTY:1. NCB CANC SCREW 5.0 32MM L85, ITEM #: 02.02152.085, LOT #: 3181233, QTY:2. NCB CANC SCREW 5.0 32MM L90, ITEM #: 02.02152.090, LOT #: 3137811, QTY:1. NCB CANC SCREW 5.0 32MM L90, ITEM #: 02.02152.090, LOT #: 3191510, QTY:1. NCB CANC SCR 5.0 32MM L95MM, ITEM #: 02.02152.095, LOT #: 3125131, QTY:1. NCB PP DIS FEM PLT L12H L278MM, ITEM #: 02.02264.112 LOT #: 3197900 QTY:1. G2. REPORT SOURCE: JAPAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, D9, G3, G6, H2, H3, H6, H11. THE DRILL WAS RETURNED FOR EXAMINATION. THE EVENT CAN BE CONFIRMED AS THE DRILL SI FRACTURED IN THE CUTTING AREA. THE SHAFT OF THE INSTRUMENT IS INCONSPICUOUS. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED. THE INSTRUMENT WAS MANUFACTURED IN 2014 AND IS USED WITH HIGH TORQUE FORCES. THEREFORE, THE EVENT REPORTED IS MOST LIKELY ATTRIBUTED TO WEAR AND TEAR FROM REPEATED USE OVER ALMOST 10 YEARS OF FIELD LIFE. MOREOVER, IT WAS REPORTED THAT ACCORDING TO THE DOCTOR, THE DRILL BROKE BECAUSE IT INTERFERED WITH A SCREW THAT HAD ALREADY BEEN INSERTED. HOWEVER, WITH THE AVAILABLE INFORMATION A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. 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

    IT WAS REPORTED THAT INITIAL OPERATION WAS PERFORMED WITH NCB PP SYSTEM. AFTER SEVERAL SCREWS WERE INSERTED, THE DRILL BROKE DUE TO INTERFERENCE WITH AN ALREADY INSERTED SCREW WHEN A NEW SCREW HOLE WAS BEING DRILLED. THE BROKEN DRILL TIP COULD NOT BE EXTRACTED AND REMAINED IN THE PATIENT'S BODY. REOPERATION IS NOT PLANNED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215622 DRILL BIT WITH QUICK COUPLING, 2-FLUTED, ø 2.5 MM, 154/180 MM INSTRUMENT, HIP HRX ZIMMER GMBH N/A 14023537 00889024298064

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SEE H11 NARRATIVE.