BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIGIDFIX FEM2.7MM B/T/B XPIN

    MDR report key: 8376375 · Received February 27, 2019

    Report

    Report Number
    1221934-2019-56507
    Event Type
    Injury
    Date Received
    February 27, 2019
    Report Date
    November 30, 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
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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). INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT AVAILABLE FOR PHYSICAL EVALUATION, HENCE, THE COMPLAINT CANNOT BE CONFIRMED. GIVEN THE INFORMATION PROVIDED, WE CANNOT DISCERN A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE. NO LOT NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A DEVICE HISTORY RECORD (DHR) REVIEW. AT THIS POINT, 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. (B)(4). THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT A REPORT RECEIVED FOR IIS (INVESTIGATOR INITIATED STUDIES) WHICH IS AN ACL REGISTRY IN (B)(6) WAS UPLOADED. THE REGISTRY GOAL IS TO CAPTURE ALL ACL PROCEDURES PERFORMED IN (B)(6) AND CURRENTLY HAVE 117 PARTICIPATING SURGEONS. ALL DATA PROVIDED FROM PARTICIPATING SURGEONS IS DE-IDENTIFIED AND CAPTURES ALL PROCEDURES/DEVICES ACROSS ALL INDUSTRY MANUFACTURERS. ON OPENING THE REPORT TO REVIEW THE INFORMATION, AFFILIATE IDENTIFIED THE IMPLANT COMPLICATION RATES FOR ALL DEPUY PRODUCTS CURRENTLY CAPTURED IN THE REGISTRY ON THE LAST PAGE OF THE REPORT. ON DISCUSSION WITH MEDICAL DIRECTOR, THE INFORMATION IS BEING PROVIDED BY THE AFFILIATE TO THE PRODUCT SAFETY FOR ENTRY INTO THE COMPLAINTS SYSTEM AS ¿INFORMATION ONLY¿ GIVEN THE DATA IS CUMULATIVE OVER THE DURATION OF THE REGISTRY; NO FURTHER INFORMATION IS AVAILABLE. THERE IS THE POTENTIAL OF DUPLICATIVE REPORTING IF ANY OF THESE CASES HAVE ALREADY BEEN INDIVIDUALLY (REPORTED TO THE COMPANY) AT THE POINT OF OCCURRENCE (FROM EITHER SURGEON/EMPLOYEE CLINICAL SPECIALIST) AS STATED BY THE AFFILIATE. THE REPORT STATES THAT 5 RIGIDFIX FEM2.7MM B/T/B XPIN; PRODUCT CODE 210127, FAILED DUE TO UNKNOWN REASONS. RE-SURGERY WAS REQUIRED TO REPAIR THE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166705 RIGIDFIX FEM2.7MM B/T/B XPIN SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US UNKNOWN 10886705000883

    Patients

    Seq Age Sex Outcome Treatment
    1