BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8X23MM MILAGRO ADVANCE INTERFERENCE SCREW

    MDR report key: 6950772 · Received October 16, 2017

    Report

    Report Number
    1221934-2017-10497
    Event Type
    Malfunction
    Date Received
    October 16, 2017
    Date of Event
    August 9, 2017
    Report Date
    August 10, 2017
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    PMA / PMN Number
    K123362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON ADDITIONAL INFORMATION RECEIVED FROM OUR AFFILIATE ON 11-7-2017, IT WAS CONFIRMED THAT THIS DEVICE WAS INITIALLY REPORTED INCORRECTLY AS A COMPLAINT DEVICE, IT WAS NOT USED IN THE PROCEDURE, AND THE INITIAL MEDWATCH FOR THIS DEVICE SHOULD NOT HAVE BEEN FILED. UDI: (B)(4). ASSOCIATED MEDWATCH: 1221934-2014-10496, 1221934-2014-10497, 1221934-2014-10498, 1221934-2014-10499.

    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). ASSOCIATED MEDWATCH: 1221934-2014-10496, 1221934-2014-10498, 1221934-2014-10499.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED VIA EMAIL THAT THE SCREW BROKEN AT THE DISTAL END DURING REGULAR ACL SURGERY. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON 08-18-2017: THE BREAKAGE OCCURRED WHILE TRIGGERED BOTH NEEDLE DELIVERED SIMULTANEOUSLY THE PATIENT HAD NORMAL BONE QUALITY. THE SURGEON USED THE ORIGINAL BONE HOLE WITH NEXT SIZE OF IMPLANTS. THE SURGEON DID NOT MAKE AN ADDITIONAL BONE HOLE TO COMPLETE THE PROCEDURE. THE BREAKAGE DID NOT RESULT IN SURGICAL DELAY OF GREATER THAN 30 MINUTES OR AN INABILITY TO COMPLETE THE PROCEDURE AS INTENDED, PROCEDURE WAS COMPLETED WITH COMPETITOR IMPLANTS SURGEON KEPT BOTH IMPLANTS INSIDE OT. THERE WERE NO PROCEDURAL OR PATIENT ANATOMY FACTORS WHICH MAY HAVE CONTRIBUTED TO THE BREAKAGE. NO SURGICAL INTERVENTION IS PLANNED. A PORTION OF THE DEVICE REMAINS IN THE PATIENT, NO PATIENT IMPACT. ADDITIONAL INFORMATION FROM AFFILIATE ON 11/07/2017: OUR SALES TEAM HAS CONFIRMED THAT THE LOT NUMBER OF THE COMPLAINT SAMPLE SENT IS THE CORRECT LOT NUMBER TO BE CONSIDERED (I.E. ONE DEVICE WITH PRODUCT CODE: 231817 FROM LOT: 3895391 & ONE DEVICE WITH PRODUCT CODE: 231821 FROM LOT 3898871).

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED VIA EMAIL THAT THE SCREW BROKEN AT THE DISTAL END DURING REGULAR ACL SURGERY. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON 8-18-2017, THE BREAKAGE OCCURRED WHILE TRIGGERED BOTH NEEDLE DELIVERED SIMULTANEOUSLY, THE PATIENT HAD NORMAL BONE QUALITY, THE SURGEON USED THE ORIGINAL BONE HOLE WITH NEXT SIZE OF IMPLANTS, THE SURGEON DID NOT MAKE AN ADDITIONAL BONE HOLE TO COMPLETE THE PROCEDURE, THE BREAKAGE DID NOT RESULT IN SURGICAL DELAY OF GREATER, THAN 30 MINUTES OR AN INABILITY TO COMPLETE THE PROCEDURE AS INTENDED, PROCEDURE WAS COMPLETED WITH COMPETITOR IMPLANTS, SURGEON KEPT BOTH IMPLANTS INSIDE OT, THERE WERE NO PROCEDURAL OR PATIENT ANATOMY, FACTORS WHICH MAY HAVE CONTRIBUTED TO THE BREAKAGE, NO SURGICAL INTERVENTION IS PLANNED, A PORTION OF THE DEVICE REMAINS IN THE PATIENT, NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732592 8X23MM MILAGRO ADVANCE INTERFERENCE SCREW MITEK ACL IMPLANTS MAI DEPUY MITEK 3895391

    Patients

    Seq Age Sex Outcome Treatment
    1