BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIGIDFIX FEM2.7MM B/T/B XPIN

    MDR report key: 8150427 · Received December 11, 2018

    Report

    Report Number
    1221934-2018-55638
    Event Type
    Injury
    Date Received
    December 11, 2018
    Date of Event
    November 20, 2018
    Report Date
    November 20, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705000883
    PMA / PMN Number
    K150209;
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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. EVALUATION STATEMENT: THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS DISCARDED BY THE CUSTOMER, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PRODUCT CODE 210127, LOT L863127 COMBINATION AND NO NON-CONFORMANCE 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. 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

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. (B)(4). THE COMPLAINT DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR PHYSICAL EVALUATION. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. IT WAS REPORTED THAT THE DEVICE WAS USED WITH EXCESSIVE FORCE WHICH MAY HAVE POTENTIALLY CONTRIBUTED TO THE REPORTED BREAKAGE; HOWEVER, A SPECIFIC ROOT CAUSE CANNOT BE DETERMINED. A NON-CONFORMANCE SEARCH WAS CONDUCTED TO INVESTIGATE ANY DEFECTS DURING PRODUCTION IDENTIFIED THAT MAY CONTRIBUTE TO THE COMPLAINT CONDITION. NO NON-CONFORMANCE WAS IDENTIFIED FOR THIS PART-LOT NUMBER COMBINATION. AT THIS TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT TO WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL RECONSTRUCTION PROCEDURE THE CUSTOMER'S RIGIDFIX CROSS PIN KIT METAL SLEEVE BROKE OFF IN THE PATIENT WHILE IT WAS BEING REMOVED. THE SALES REP STATED THAT THE CROSS PINS TRAVEL THROUGH THE METAL SLEEVES INTO THE FEMUR. THE SALES REP STATED THAT THE PATIENT HAD HARD BONE AND THERE WAS EXCESSIVE FORCE BEING USED WHILE THE DEVICE WAS REMOVED. THE BREAKAGE OCCURRED AT THE END OF THE CASE, SO THE PROCEDURE WAS COMPLETED WITH THIS DEVICE WITH NO DELAY. THE SURGEON DID NOT REMOVE THE METAL PIECE FROM THE PATIENT, WHICH THE SALES REP STATED IS NO LARGER THAN THREE CENTIMETERS. THERE IS NO SURGICAL INTERVENTION PLANNED. THE DEVICE WAS DISCARDED BY THE CUSTOMER. THERE WAS PATIENT INVOLVEMENT REPORTED. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. 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
    991739 RIGIDFIX FEM2.7MM B/T/B XPIN SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US L863127 10886705000883

    Patients

    Seq Age Sex Outcome Treatment
    1 Other