BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROQA+ W/#4OC P3

    MDR report key: 8326391 · Received February 11, 2019

    Report

    Report Number
    1221934-2019-56378
    Event Type
    Injury
    Date Received
    February 11, 2019
    Date of Event
    January 21, 2019
    Report Date
    April 4, 2019
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HWC
    UDI-DI
    10886705001880
    PMA / PMN Number
    K080352
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AND INSPECTED. THE COMPLAINT CAN BE CONFIRMED. THE SUTURE WAS OBSERVED TO BE CUT IN HALF. THE INSERTER OF THE DEVICE WAS INSPECTED FOR ANY GROSS VISUAL DEFECTS THAT MAY CONTRIBUTE TO THE COMPLAINT CONDITION, HOWEVER NONE WE OBSERVED. IT IS POSSIBLE THAT THE BONE SURROUNDING THE INSERTION SITE OF THE IMPLANT WAS ROUGH. PER THE IFU, IF THE BONE SURROUNDING THE INSERTION SITE IS ROUGH, THE SUTURES CAN BECOME DAMAGED IF THEY COME IN CONTACT WITH THE ROUGH BONE DURING INSERTION THEREFORE IS A POTENTIAL ROOT CAUSE FOR THE SUTURE BREAKAGE EXPERIENCED BY THE CUSTOMER. HOWEVER, GIVEN THE INFORMATION PROVIDED WE CANNOT DISCERN A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE. A NON-CONFORMANCE SEARCH WAS CONDUCTED TO INVESTIGATE ANY DEFECTS IDENTIFIED DURING PRODUCTION THAT MAY CONTRIBUTE TO THE COMPLAINT CONDITION. NO NON-CONFORMANCE WAS IDENTIFIED FOR THIS PART-LOT NUMBER COMBINATION. 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. UDI: (B)(4). THE EXPIRATION DATE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4). THE EXPIRATION DATE IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE VIA CST TOOL THAT DURING AN EXTENSOR TENOLYSIS, IFP CAPSULOTOMY, INSERTION TENORRAFIA OF THE EXTENSOR OF THE FIFTH FINGER OF THE RIGHT HAND THE MICROQA+'S ORTHOCORD SUTURE WITH NEEDLE BROKE. THE ORTHOCORD SUTURE STRANDS WERE REMOVED FROM THE PATIENT AND A DIFFERENT SUTURE WAS USED TO REPAIR THE TENDON. THE SURGERY WAS PERFORMED SUCCESSFULLY WITHOUT ANY PATIENT CONSEQUENCES, BUT A 15 MINUTES DELAY. HOWEVER, THE TITANIUM ANCHOR WAS LEFT INSIDE THE PATIENT. THE ANCHOR DID NOT FULFILL IT'S FUNCTION AND REMAINED WITHIN THE BONE WITHOUT CAUSING ANY AFFECTATION TO THE PATIENT AND THE SURGEON STATES THAT IT IS NOT NECESSARY TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120040 MICROQA+ W/#4OC P3 SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE HWC MEDOS INTERNATIONAL SARL L768019 10886705001880

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR