BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5 HEALIX TI ANCHR W/OC +NDLS

    MDR report key: 8975562 · Received September 9, 2019

    Report

    Report Number
    1221934-2019-58223
    Event Type
    Malfunction
    Date Received
    September 9, 2019
    Date of Event
    August 12, 2019
    Report Date
    August 12, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MBI
    UDI-DI
    10886705007882
    PMA / PMN Number
    K082282
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: H3, H4, H6 INVESTIGATION SUMMARY. THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS DISCARDED BY THE CUSTOMER, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. HOWEVER A PHOTO WAS PROVIDED. UPON VISUAL INSPECTION OF THE PHOTO, THE SUTURE WAS OBSERVED COMPLETELY BROKEN. THE REPORTED COMPLAINT WAS CONFIRMED. THE PHOTO DO NOT PROVIDE ENOUGH EVIDENCE TO DETERMINE ROOT CAUSE. HANDS ON ANALYSIS SHOULD PROVIDE THE EVIDENCE NECESSARY TO CONFIRM THE ROOT CAUSE. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PRODUCT CODE 222242, LOT #2L82128 COMBINATION AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. DEVICE HISTORY: NO NONCONFORMANCES WERE IDENTIFIED FOR THIS PART NUMBER, LOT NUMBER COMBINATION PER QLIK QUERY EXECUTED ON (B)(6)2019. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: HWC, JDR. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW / INVESTIGATION. FACILITY INFORMATION NOT AVAILABLE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING AN ACHILLES REPAIR PROCEDURE ON (B)(6) 2019, THE SUTURES BREAK WHEN PULLING SUTURES FOR CLOSURE. THE SURGERY WAS COMPLETED SUCCESSFULLY. SURGICAL DELAY AND PATIENT STATUS ARE UNKNOWN. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771891 5.5 HEALIX TI ANCHR W/OC +NDLS FASTENER,FIXATION,NONDEGRADABLE, SOFT TISSUE MBI DEPUY MITEK LLC US 222242 2L82128 10886705007882

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR