BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRUCIATE+ BEATH PIN BULLET

    MDR report key: 8756231 · Received July 2, 2019

    Report

    Report Number
    1221934-2019-57512
    Event Type
    Malfunction
    Date Received
    July 2, 2019
    Date of Event
    January 1, 2019
    Report Date
    June 5, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    LXH
    UDI-DI
    10886705025855
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # : (B)(4). DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. THE COMPLAINT DEVICE IS NOT BEING RETURNED FOR EVALUATION, THEREFORE A PHYSICAL EVALUATION CANNOT BE PERFORMED. THE COMPLAINT EVENT WAS REPORTED TO HAVE OCCURRED DURING USE ON A CADAVER. A PHOTO WAS SUPPLIED AT THE TIME THE COMPLAINT WAS CREATED, THIS WILL BE USED TO EVALUATE THE COMPLAINT DEVICE. THE PHOTO REVEALED THE KNOB WAS DETACHED FROM THE BULLET, AND A DRILL BIT APPEARED TO BE STUCK INSIDE THE BULLET. THIS COMPLAINT CAN BE CONFIRMED. THE PHOTO WAS REVIEWED BY AN NPD ENGINEER AS PART OF THE EVALUATION. THE NPD ENGINEER CONCLUDED THAT THE DRILL PIN LIKELY GOT GALLED UP IN THE BULLET, AND IN TRYING TO GET THEM DECOUPLED, THE WELD BETWEEN THE BULLET AND HANDLE FAILED. IF THE DRILL PIN WAS NOT STRAIGHT, IT COULD HAVE STARTED TO GALL DURING THE DRILLING, WHICH EVENTUALLY CAUSED IT TO SEIZE TOGETHER. A MANUFACTURING RECORD EVALUATION CANNOT BE CONDUCTED AS NO LOT NUMBERS WERE PROVIDED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4). THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT THE FAILURE OF THE CRUCIATE+ BEATH PIN BULLET WAS IDENTIFIED DURING ITS CORRECT USE IN A CADAVEROUS COURSE, THE BEATH PIN 14'', WHICH WAS A PART OF THE DISPOSABLE KIT GOT TRAPPED AND LOCKED INSIDE THE BULLET. WHEN TRYING TO RELEASE IT, THE BULLET WAS BROKEN AND WAS REMAINING IN 2 PARTS IMAGES ATTACHED. BUT STILL THE DRILL DID NOT COME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548500 CRUCIATE+ BEATH PIN BULLET LIGAMENT RECONSTRUCTION INSTRUMENT SET LXH MEDOS INTERNATIONAL SàRL UNKNOWN 10886705025855

    Patients

    Seq Age Sex Outcome Treatment
    1