BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUPINE BR W/ORTHCRD

    MDR report key: 7989978 · Received October 22, 2018

    Report

    Report Number
    1221934-2018-55011
    Event Type
    Malfunction
    Date Received
    October 22, 2018
    Date of Event
    September 28, 2018
    Report Date
    September 29, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705001095
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    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 ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATION CONFIRMS THAT THE ANCHOR IS BROKE IN HALF AND THE DISTAL HALF WAS NOT RETURNED. IT WAS OBSERVED THAT THE SUTURES WERE NOT ATTACHED TO THE ANCHOR AND THEY WERE SEPARATELY WRAPPED AROUND THE INSERTER. WE CANNOT DETERMINE AT WHAT POINT THIS FAILURE OCCURRED. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PART(210711), LOT(L563081) COMBINATION AND NO NON-CONFORMANCE'S WERE IDENTIFIED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. 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.

    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 DFA. 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. 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. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATION CONFIRMS THAT THE ANCHOR IS BROKE IN HALF AND THE DISTAL HALF WAS NOT RETURNED. IT WAS OBSERVED THAT THE SUTURES WERE NOT ATTACHED TO THE ANCHOR AND THEY WERE SEPARATELY WRAPPED AROUND THE INSERTER. WE CANNOT DETERMINE AT WHAT POINT THIS FAILURE OCCURRED. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PART(210711), LOT(L563081) COMBINATION AND NO NON-CONFORMANCE'S WERE IDENTIFIED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. 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).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 10/19/2018 STATED THAT THE DEVICE BREAK WHILE BEING INSERTED, ALL THE BROKEN FRAGMENTS WERE REMOVED. PATIENT HAS NORMAL BONE QUALITY. THE PROCEDURE SAS BANKART WAS COMPLETED WITH ANOTHER LUPINE USING THE ORIGINAL BONE HOLE. THERE WAS AROUND 2 MINUTES OF SURGICAL DELAY.

    Additional Manufacturer Narrative · 1

    (B)(4). AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. 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 AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THEIR LUPINE ANCHOR DEVICE BROKE DURING INSERTION. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. 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
    833789 LUPINE BR W/ORTHCRD SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US L563081 10886705001095

    Patients

    Seq Age Sex Outcome Treatment
    1