BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HWC

    MDR report key: 9379083 · Received November 26, 2019

    Report

    Report Number
    1221934-2019-59800
    Event Type
    Malfunction
    Date Received
    November 26, 2019
    Date of Event
    August 7, 2019
    Report Date
    August 28, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HTY
    UDI-DI
    10886705000890
    PMA / PMN Number
    K010633
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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. OUTCOMES ATTRIBUTED TO ADVERSE EVENT: ADDITIONAL PROCODE: MAI. INITIAL REPORTER OCCUPATION IS A MITEK EMPLOYEE. 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 · 0

    THE PROCEDURE TOOK PLACE ON (B)(6) 2019.

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. INVESTIGATION SUMMARY: THE COMPLAINT DEVICES WERE RECEIVED AND EVALUATED. THERE WERE FOUR TROCARS AND THREE DRILL BITS RECEIVED. TWO THAT THE DRILL BITS AND THE TROCAR STUCK TOGETHER AND TWO TROCARS AND ONE DRILL BIT THAT VISUALLY SHOWED NO ANOMALIES. VISUAL OBSERVATION CONFIRMS THAT THE SLEEVES AND TROCARS ARE WELDED TOGETHER. IT WAS OBSERVED THAT THE OUTER SURFACES OF THE SLEEVES HAD STRIATIONS ON IT INDICATING THAT IT WAS LOOSELY FIT INSIDE THE GUIDE FRAMES. HISTORICALLY, THERE ARE A COUPLE OF KNOWN FACTORS THAT HAVE BEEN OBSERVED WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS TYPE FAILURE MODE: IF THE PINS ON THE TROCAR ARE NOT FULLY SEATED IN THE SLEEVE PRIOR TO THE ROTATION OF THE TROCAR. IF THERE IS PRESSURE APPLIED TO THE SIDE OF THE SYSTEM (NOT DRILLING IN LINE), AND ANOTHER FACTOR IS IF THE FRAME IS OUT OF STRAIGHTNESS. ALL OF THESE FACTORS WILL CAUSE THE FRAME TO BIND WITH THE SLEEVE/TROCAR RESULTING IN WELDING OF THE TWO PARTS. THIS FAILURE CAN BE ATTRIBUTED TO USER TECHNIQUE. NO NONCONFORMANCES WERE IDENTIFIED FOR THIS PART NUMBER, LOT NUMBER COMBINATION PER QLIK QUERY EXECUTED ON (B)(6) 2019. 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 HISTORY LOT. NO NON-CONFORMANCES WERE IDENTIFIED FOR THIS PART NUMBER, LOT NUMBER COMBINATION PER QLIK QUERY EXECUTED ON (B)(6) 2019. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE DRILL SLEEVES DID NOT CORRESPOND TO THE GUIDE SLEEVE. THE PATIENT WAS NOT HURT, AND THE SURGERY TIME WAS NOT EFFECTED-COMPLETED WITH THE SAME ARTICLE. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175060 HWC UNK HTY DEPUY MITEK LLC US 210133 1L85767 10886705000890

    Patients

    Seq Age Sex Outcome Treatment
    1