BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWISTR ACL DISPOSABLES KIT

    MDR report key: 8958076 · Received September 3, 2019

    Report

    Report Number
    1221934-2019-58184
    Event Type
    Malfunction
    Date Received
    September 3, 2019
    Date of Event
    January 1, 2019
    Report Date
    September 3, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    KDD
    UDI-DI
    10886705026173
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS NOT RETURNED, 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 WAS USED TO EVALUATE THE COMPLAINT DEVICE. THE PHOTO REVEALED THE DISTAL TIP OF THE 14 INCH DRILL PIN WAS EXTENDING OUT OF THE BULLET, APPEARED TO BE BENT AT THE TIP, AND WAS BROKEN OFF COMPLETELY WHERE IT COMES OUT OF THE OTHER END OF THE BULLET. THE DRILL PIN APPEARS TO BE STUCK INSIDE THE BULLET, AS REPORTED IN THE EVENT DESCRIPTION. THIS COMPLAINT IS 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. IT IS LIKELY THAT THE DRILL PIN BROKE INTO TWO PIECES DURING THE ATTEMPT TO REMOVE THE STUCK PIN FROM THE BULLET, AT THE SAME TIME THE HANDLE BROKE OFF THE BULLET. 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. UDI: (B)(4). THE LOT NUMBER IS UNKNOWN. 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.

    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. THE RECEIVED PHOTO WAS REVIEWED BY MANUFACTURER AND IT SHOWS A RESTORE ACL INSTRUMENTS 14" DRILL PT. PIN W/EYELET STUCK INSIDE THE BULLET COMPLAINT DEVICE. IT IS CLEAR IN THE PHOTO THAT THE DRILL PIN IS ABOUT HALF THE LENGTH IT IS SUPPOSED TO BE AND ALSO APPEARS BENT AT THE TIP. THE DRILL PIN IS PART OF THE FINISHED GOODS ACL DISPOSABLE KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750805 TWISTR ACL DISPOSABLES KIT LIGAMENT RECONSTRUCTION INSTRUMENT SET KDD MEDOS INTERNATIONAL SàRL UNKNOWN 10886705026173

    Patients

    Seq Age Sex Outcome Treatment
    1