BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6MM X 30MM MILAGRO SCREW

    MDR report key: 6900609 · Received September 28, 2017

    Report

    Report Number
    1221934-2017-10544
    Event Type
    Injury
    Date Received
    September 28, 2017
    Date of Event
    August 31, 2017
    Report Date
    September 28, 2017
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    PMA / PMN Number
    K150209
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATION CONFIRMS THE SCREW WAS COMPLETELY BROKEN INTO NUMBER OF PIECES AND THERE WERE STAINS ON THE BROKEN PIECES. THIS COMPLAINT CAN BE CONFIRMED. TYPICALLY, ANCHOR BREAKAGE AND ANCHOR PULL OUTS ARE ASSOCIATED WITH OFF AXIS INSERTION, INCOMPLETE INSERTION INTO THE BONE HOLE, USING INSTRUMENTS NOT INDICATED TO BE USED WITH THE ANCHOR AND POOR BONE QUALITY. OTHER THAN THIS POSSIBILITY, WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED FAILURE. FURTHER, A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED ONE OTHER SIMILAR COMPLAINT FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. 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).

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED VIA EMAIL THAT THE SF SCREW (P/N AND LOT NUMBER WERE UNKNOWN) WAS PULLED AFTER 1ST ACL RECONSTRUCTION SURGERY, THEN SURGEON ATTEMPTED TO FIX WITH SCREW IN QUESTION. HOWEVER, THE SCREW IN QUESTION WAS ALSO PULLED OUT FROM THE POST-OPERATIVE BONE ON (B)(6) 2017. THE SURGERY WAS PERFORMED ONLY WITH NAILING OUT OF THE SCREW IN QUESTION. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS SURGICAL NO DELAY. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON 9-8-2017. PRODUCT CODE 231809 AND LOT NUMBER 3795838. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON 9-11-2017. THE ORIGINAL SURGERY DATE IS UNDER INQUIRY TO THE SALES PERSON. NO INFORMATION IS AVAILABLE ON THE TYPE OF ANCHOR THAT WAS USED. THE REASON FOR THE FIRST RE-SURGERY WAS BECAUSE THE ANCHOR CAME OUT ON (B)(6), PRODUCT CODE 231809 LOT NUMBER 3795838 WAS REMOVED. THE REASON FOR REMOVING THIS ANCHOR WAS BECAUSE THE ANCHOR(MILAGRO BR) COME OUT. NO INFORMATION IS AVAILABLE IF EVERYTHING WAS REMOVED. NO INFORMATION IS AVAILABLE ON WHAT IS MEANT BY NAILING OUT OF THE SCREW IN QUESTION. NO INFORMATION IS AVAILABLE HOW THE PROCEDURE WAS COMPLETED. NO INFORMATION IS AVAILABLE IF THE HEALING WAS COMPLETE. YES, THE DEVICE WILL BE RETURNED FROM THE CUSTOMER. ONCE WE RECEIVED IT, WE WILL SHIP IT TO YOUR SITE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON 9-25-2017. WE HAVE NO INFORMATION REGARDING ¿SF¿ SCREW PROVIDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682537 6MM X 30MM MILAGRO SCREW ORTHOPAEDIC BONE SCREW, BIOABSORBABLE MAI DEPUY MITEK 3795838

    Patients

    Seq Age Sex Outcome Treatment
    1 Other