BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6X12 MILAGRO INTERFRENCE SCREW

    MDR report key: 8033071 · Received November 2, 2018

    Report

    Report Number
    1221934-2018-55164
    Event Type
    Malfunction
    Date Received
    November 2, 2018
    Date of Event
    October 15, 2018
    Report Date
    October 15, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    GEI
    UDI-DI
    10886705021956
    PMA / PMN Number
    K143660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS DISCARDED BY THE CUSTOMER, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. FURTHER, NO LOT NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A DEVICE HISTORY RECORD (DHR) REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. 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, (B)(4) 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). DEPUY SYNTHES HAS BEEN INFORMED THAT THE LOT NUMBER IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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 PART (231813) AND LOT (3914532) 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. 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 · 0

    ADDITIONAL INFORMATION RECEIVED FROM SALES REPRESENTATIVE ON (B)(6) 2018: THE LOT NUMBER WAS PROVED AS 3914932; HOWEVER, THE CONSIGNMENT TEAM INDICATED THE LOT PROVIDED WAS INVALID. THERE WERE NO PROCEDURAL OR PATIENT ANATOMY FACTORS WHICH MAY HAVE CONTRIBUTED TO THE BREAKAGE. THE PATIENT¿S BONE QUALITY WAS NOTED AS NORMAL. THE INSERTION WAS NOT OFF AXIS. THE SAME BONE HOLE WAS USED TO COMPLETE THE PROCEDURE. THE TUNNEL AND GRAFT SIZE WERE SIX MILLIMETERS (6MM). NO TRIALING WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. (B)(4)-INCOMPLETE THE LOT NUMBER IS CURRENTLY UNAVAILABLE; THEREFORE, THE EXP DATE IS UNAVAILABLE. THE COMPLAINT DEVICE IS NOT BEING RETURNED AS IT WAS DISCARDED BY THE CUSTOMER; THEREFORE, THIS COMPLAINT CANNOT BE CONFIRMED AND DUPLICATED. THE ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A FHL TRANSFER PROCEDURE, IT WAS OBSERVED THAT MILAGRO INTERFERENCE SCREW 6X12MM DEVICE BROKE MID-BODY WHILE BEING INSERTED. THE SALES REP STATED THAT THE HOLE HAD BEEN DRILLED AND THE SCREW BROKE WHILE BEING TAPPED IN. THE SCREW WAS REMOVED WITH NO DEBRIS LEFT BEHIND. THE CASE WAS COMPLETED WITH A NEW SCREW IN THE SAME BONE HOLE WITH NO PATIENT HARM OR DELAY. THE DEVICE WAS DISCARDED BY THE CUSTOMER. 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
    875174 6X12 MILAGRO INTERFRENCE SCREW ORTHOPAEDIC BONE SCREW, BIOABSORBABLE GEI DEPUY MITEK LLC US 3914532 10886705021956

    Patients

    Seq Age Sex Outcome Treatment
    1