BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAS FIX PIN 3.2D X 80MM STR

    MDR report key: 14498905 · Received May 25, 2022

    Report

    Report Number
    0009617840-2022-00023
    Event Type
    Injury
    Date Received
    May 25, 2022
    Date of Event
    April 21, 2022
    Report Date
    September 14, 2022
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    UDI-DI
    00889024563636
    PMA / PMN Number
    K182964
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT:(B)(4). AN INVESTIGATION INTO THIS INCIDENT IS CURRENTLY UNDERWAY. ONCE THE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE MADE AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED. FRAGMENTED PIN IS STILL IN PATIENT.

    Additional Manufacturer Narrative · 0

    THE FRACTURED SCREW WAS UNABLE TO BE RETURNED TO THE PRODUCT SURVEILLANCE TEAM AS IT WAS DISCARDED BY THE SITE. POST-OPERATIVE X-RAYS WERE PROVIDED OF THE PATIENT'S KNEE AND REVIEWED BY A SUBJECT MATTER EXPERT (SME). THE SME CONFIRMED THAT A SMALL METALLIC FRAGMENT WAS RETAINED IN THE KNEE FOLLOWING THE OPERATION. THE LOT NUMBER WAS REVIEWED FOR ANY DEVIATIONS AND/OR ANOMALIES IN THE MANUFACTURING PROCESS THAT MAY HAVE CONTRIBUTED TO THIS REPORTED EVENT. NO DEVIATIONS OR ANOMALIES WERE DISCOVERED; THEREFORE, IT IS NOT EXPECTED THAT THE MANUFACTURING PROCESS CONTRIBUTED TO THE REPORTED ISSUE. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE. POTENTIAL CONTRIBUTING FACTORS MAY INCLUDE EXCESSIVE FORCE APPLIED DURING INSERTION OR REMOVAL. 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 DURING TKA USING ROBOTIC ASSISTED INSTRUMENTATION, A PIN SNAPPED WITHIN THE PATIENT. PROPER SURGICAL TECHNIQUE WAS USED WHEN INSERTING THE PINS INTO THE TIBIA. FIRST PIN WAS PLACE PROXIMALLY AND SECOND PIN DISTAL TO THAT. THE DISTAL PIN WENT THROUGH THE NEAR CORTEX FINE AND PROCEEDED TO 'STOP' PROGRESSING INTO THE BONE. WHEN THE SURGEON ATTEMPTED TO BACK THE PIN OUT AND INSPECT WHAT OCCURRED. HE NOTICED THAT THE PIN WAS BROKEN. IT WAS NOTED THAT THE PATIENT DID NOT HAVE UNUSUALLY DENSE BONE NOR WEAK BONE. THIS EVENT OCCURRED AT THE TIME OF PLACING THE TRACKERS PRIOR TO REGISTRATION. THERE WAS A 30-45 MINUTE DELAY IN PROCEDURE. ADDITIONAL SKIN INCISION AND PIN REQUIRED. THE SURGEON ATTEMPTED TO REMOVE THE PIN INTRA-OPERATIVELY BUT WAS UNABLE TO DO SO AS THE PIN ANCHORED INTO POSTERIOR CORTICAL BONE. NO KNOWN IMPACT TO THE PATIENT, AT THIS TIME THE PIN REMAINS IMPLANTED IN PATIENT. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2094917 CAS FIX PIN 3.2D X 80MM STR ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS N/A 65221983 00889024563636

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Other