BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFIX QA+#3/0 OC V-4W/BIT

    MDR report key: 6734276 · Received July 21, 2017

    Report

    Report Number
    1221934-2017-10380
    Event Type
    Malfunction
    Date Received
    July 21, 2017
    Date of Event
    August 18, 2016
    Report Date
    July 21, 2017
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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). EXPIRATION DATE INFORMATION IS NOT AVAILABLE AT THIS MOMENT. ASSOCIATED MEDWATCH: 1221934-2017-10381.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: IT WAS REPORTED THAT THE COMPLAINT DEVICE WILL NOT BE RETURNED; THEREFORE A PHYSICAL EVALUATION CANNOT BE CONDUCTED. THE REPORTED COMPLAINT CANNOT BE CONFIRMED AND A ROOT CAUSE THE REPORTED DEVICE FAILURE CANNOT BE DETERMINED. A DHR REVIEW AND A RELATED COMPLAINT SEARCH FOR THIS LOT COULD NOT BE PERFORMED BECAUSE THE REPORTED LOT NUMBER IS INVALID. IT WAS REPORTED THAT THE REPORTED LOT NUMBER WAS THE INFORMATION GIVEN TO THE SALES REP AT THE TIME, AND THE CORRECT LOT NUMBER FOR THIS PRODUCT IS UNKNOWN. AT THIS TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY TO MONITOR THE EXTENT TO WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. UDI: (B)(4) - INCOMPLETE. THE REPORTED LOT NUMBER IS INVALID AND THE CORRECT LOT NUMBER FOR THE DEVICE IS UNKNOWN. SEE ASSOCIATED MEDWATCH: 1221934-2017-10381.

    Additional Manufacturer Narrative · 1

    NEW INFORMATION REGARDING THE REPORTABILITY OF THE REPORTED CONDITION WAS RECEIVED FROM THE MEDICAL SAFETY TEAM ON JULY 21ST, 2017. THE ISSUE WAS DISCUSSED WITH THE COMPLAINTS GROUP ON AUGUST 1ST, 2017 AND FILED TODAY TO REFLECT THE CHANGES AND CORRECTIONS. ADDITIONAL NARRATIVE: 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

    THE AREA VICE PRESIDENT (AVP) REPORTED VIA PHONE THAT TWO MICROFIX QA + 3/0 ORTHOCORD V-4 W/BIT *E-EO DID NOT HOLD IN THE BONE AND WERE PULLED OUT DURING A HAND PROCEDURE. THE AVP STATED THAT NEITHER HE OR THE CUSTOMER COULD PROVIDE ANYMORE DETAILS FOR THE CASE. THE DEVICES ARE BEING RETURNED.

    Description of Event or Problem · 1

    THE AREA VICE PRESIDENT (AVP) REPORTED VIA PHONE THAT TWO MICROFIX QA + 3/0 ORTHOCORD V-4 W/BIT *E-EO DID NOT HOLD IN THE BONE AND WERE PULLED OUT DURING A HAND PROCEDURE. THE AVP STATED THAT NEITHER HE OR THE CUSTOMER COULD PROVIDE ANYMORE DETAILS FOR THE CASE. THE DEVICES ARE BEING RETURNED. THE CUSTOMER STATED VIA PHONE THAT THE DEVICES ARE NOT AVAILABLE TO BE RETURNED ON JULY 13, 2017. THE REPORTED LOT NUMBER OF 2873160 WAS FOUND TO BE AN INVALID LOT NUMBER. ON APRIL 11, 2018 IT WAS REPORTED BY THE AVP THAT THE REPORTED LOT NUMBER WAS THE INFORMATION GIVEN TO HIM AT THE TIME, AND THE CORRECT LOT NUMBER FOR THIS PRODUCT IS UNKNOWN. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513665 MICROFIX QA+#3/0 OC V-4W/BIT SOFT-TISSUE ANCHOR MAI DEPUY MITEK LLC US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1