BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RGDFX CRVE ST ACL PLA XPIN SYS

    MDR report key: 8667785 · Received June 4, 2019

    Report

    Report Number
    1221934-2019-57301
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    May 9, 2019
    Report Date
    May 10, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HTY
    PMA / PMN Number
    K130105
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS DISCARDED BY THE CUSTOMER, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. NR-0102207 WAS IDENTIFIED FOR THIS PART NUMBER, LOT NUMBER PER QLIK QUERY EXECUTED ON 5/28/2019. THE COMPLAINT CONDITION IS UNRELATED TO THE NONCONFORMANCE. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. IF ANY ADDITIONAL INFORMATION IS OBTAINED, THIS COMPLAINT WILL BE RE-OPENED TO CAPTURE THAT INFORMATION. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT THE RIGIDFIX CURVE SOFT TISSUE ACL CROSS PIN SYSTEM DRILL PARTS BROKE OFF. THE SLEEVE COULD NOT BE PLACED PROPERLY DUE TO THIS ISSUE. THE SLEEVE AND THE DRILL SEALED TOGETHER DUE TO THE SPEED OF THE DRILL. THERE WAS NO HARM TO THE PATIENT, BUT THERE WAS A FOUR MINUTE SURGICAL DELAY. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THAT THE EVENT OCCURRED DURING A KNEE VKB AND THE CASE WAS COMPLETED WITH A NEW READILY AVAILABLE IMPLANT. THE AFFILIATE ALSO REPORTED THERE IS NO SURGICAL INTERVENTION PLANNED AND IT WAS UNKNOWN IF A NEW BONE HOLE WAS UTILIZED TO COMPLETE THE PROCEDURE. IT WAS ALSO REPORTED THAT SMALL PIECES OF THE DRILL DID BREAK OFF BUT ALL PARTS WERE REMOVED AND NOTHING REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462357 RGDFX CRVE ST ACL PLA XPIN SYS SOFT-TISSUE ANCHOR, BIOABSORBABLE HTY DEPUY MITEK LLC US L909499

    Patients

    Seq Age Sex Outcome Treatment
    1