BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGIDFIX FEM 3.3MM S/T XPIN

    MDR report key: 8264004 · Received January 21, 2019

    Report

    Report Number
    1221934-2019-56059
    Event Type
    Malfunction
    Date Received
    January 21, 2019
    Date of Event
    August 17, 2016
    Report Date
    August 17, 2016
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HTY
    UDI-DI
    10886705000890
    PMA / PMN Number
    K974341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    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 ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4). INVESTIGATION SUMMARY: A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PRODUCT CODE 210133, LOT 3860720 COMBINATION AND NO NON-CONFORMANCES WERE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4). THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATION REVEALS WEAR AND TEAR OF THE TROCAR SHAFT. THE LOCKING PINS ON THE TROCAR IS SHEARED OFF, CONFIRMING THIS COMPLAINT. IT WAS OBSERVED THAT THE OUTER SURFACE OF THE SLEEVES HAD STRIATIONS ON THEM INDICATING THAT THEY WERE LOOSELY FIT INSIDE THE GUIDE FRAME. ALSO, THE TROCAR COULD NOT BE SMOOTHLY INSERTED INTO THE SLEEVES, THERE WERE STRIATIONS AROUND THE INNER SURFACE OF THE SLEEVES AS WELL. IT IS POSSIBLE THAT THE PIN ON THE TROCAR WAS NOT FULLY SEATED IN THE SLEEVE PRIOR TO THE ROTATION OF THE TROCAR, WHICH CAUSED THE PIN TO SHEAR OFF. THIS FAILURE CAN BE ATTRIBUTED TO USER TECHNIQUE. FURTHER, A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINT FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT IN TIME, 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. THIS REPORT IS BEING FILED FROM THE ETQ COMPLAINT MANAGEMENT SYSTEM AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SMALL PINS NEAR THE TOP OF THE RIGIDFIX FEM 3.3MM S/T XPIN TROCAR DEVICE THAT LOCK INTO THE SLEEVE BROKE OFF. ACCORDING TO THE REPORTER, THE EVENT OCCURRED WHEN TRYING TO PUT THE SHAFT INTO THE FEMORAL GUIDE TO PROCEED GRAFT FIXATION. IT WAS FURTHER REPORTED THAT THIS EVENT PREVENTED THE FITTING OF THE SHAFT EXCEPT ITS PIN. THERE WAS A DELAY OF TEN MINUTES IN THE SURGICAL PROCEDURE TO OBTAIN A SPARE DEVICE. IT WAS REPORTED THAT NOTHING FELL INTO THE PATIENT. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56637 RIGIDFIX FEM 3.3MM S/T XPIN SOFT-TISSUE ANCHOR, BIOABSORBABLE HTY DEPUY MITEK LLC US 3860720 10886705000890

    Patients

    Seq Age Sex Outcome Treatment
    1