BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZNN¿¢, CMN LAG SCREW REAMER, SHORT

    MDR report key: 20294314 · Received September 24, 2024

    Report

    Report Number
    0009613350-2024-00465
    Event Type
    Injury
    Date Received
    September 24, 2024
    Date of Event
    August 24, 2024
    Report Date
    January 22, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    HAW
    UDI-DI
    00889024276260
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A1, A2, A3, A4, B4, B7, E1, E3, G3, G6, H2, H11.

    Additional Manufacturer Narrative · 0

    (B)(4). G2. REPORT SOURCE: FRANCE. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. T D10. FREEHAND TARGETING DRILL 4.3 MM DIAMETER ITEM# 00249007243 LOT# 66283054. CM LAG SCREW STOP ASSEMBLY ITEM# 00249000345 LOT# UNKNOWN. CMN FEMORAL NAIL, CCD 125°, LEFT, ø 11.5 MM, 21.5 CM ITEM# 47249321111 LOT# 3190859. 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD ITEM# 47248403250 LOT# 66640486. Z NAIL 10.5 X 95 LAG SCREW ITEM# 47248509510 LOT# 3201506. TWO LAG SCREW REAMERS WERE RETURNED FOR INVESTIGATION ALONG WITH TWO FREEHAND TARGETING DRILL AND ONE CM LAG SCREW STOP ASSEMBLY TO THE PRODUCT SURVEILLANCE TEAM FOR EXAMINATION. THE SHAFTS OF THE LAG SCREW REAMERS SHOW SIGNS OF NORMAL USAGE, BUT IT IS OVERALL INCONSPICUOUS. THE CUTTING EDGES OF THE INSTRUMENTS ARE FRACTURED. NO FRAGMENTS WERE RETURNED. BOTH FREEHAND TARGETING DRILLS AS WELL AS THE CM LAG SCREW STOP ASSEMBLY ARE INCONSPICUOUS WITH NORMAL SIGNS OF WEAR. OF NOTE, IT IS NOT POSSIBLE TO DISTINGUISH WHICH LAG SCREW REAMER BELONGS TO THIS COMPLAINT, AS BOTH LAG SCREW REAMERS WERE RETURNED TO THE PRODUCT SURVEILLANCE TEAM TOGETHER AND BOTH LAG SCREW REAMERS HAVE THE SAME LOT NUMBER. BOTH LAG SCREW REAMERS WERE HANDLED BY THE SAME SURGEON WITH DIFFERENT EVENT DATES. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. DEVICE IS USED FOR TREATMENT. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND THE PART AND LOT COMBINATION. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. BASED ON THE ANALYSIS OF THE RETURNED INSTRUMENT, A FRACTURE OF THE LAG SCREW REAMER CAN BE CONFIRMED. THE REVIEW OF THE SURGICAL TECHNIQUE SUGGESTS THAT USING THE WRONG CCD ANGLE DURING ASSEMBLY OF THE LAG SCREW REAMER ON THE TARGETING GUIDE COULD POTENTIALLY LEAD TO IMPINGEMENT OF THE TIP OF THE LAG SCREW ON THE NAIL, WHICH MIGHT CONTRIBUTE TO THE FRACTURE OF THE REAMER. HOWEVER, WITH THE AVAILABLE INFORMATION, IT IS IMPOSSIBLE TO REPRODUCE THE REPORTED EVENT, AND 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

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN A SURGERY, DURING THE INSERTION OF A PERTROCHANTERIC NAIL, AT THE END OF THE PROCEDURE, THE DISTAL END OF THE DRILL WAS FOUND TO BE BROKEN. THE MISSING FRAGMENTS WERE NOT PRESENT IN THE ANCILLARY BOX AND WERE NOT RECOVERED/SEARCHED, AS THE BREAKAGE WAS NOT FELT BY THE OPERATOR. NO CLINICAL CONSEQUENCES WERE OBSERVED. DUE DILIGENCE IS IN PROCESS AND TO DATE NO ADDITIONAL 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
    1869652 ZNN¿¢, CMN LAG SCREW REAMER, SHORT INSTRUMENT, TRAUMA HAW ZIMMER GMBH N/A 4505035466 00889024276260

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other SEE H11 NARRATIVE.