BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUPINE BR W/ORTHCRD

    MDR report key: 9745964 · Received February 24, 2020

    Report

    Report Number
    1221934-2020-00667
    Event Type
    Malfunction
    Date Received
    February 24, 2020
    Date of Event
    November 22, 2019
    Report Date
    February 21, 2020
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705001095
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    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. 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. UPON VISUAL OBSERVATION, THAT THE BIOCRYL ANCHOR WAS FOUND TO BE BROKEN INTO TWO PIECES AND THE BROKEN DISTAL PART WAS RETURNED AT CQ. IT WAS OBSERVED THAT THE SUTURES WERE ATTACHED TO THE ANCHOR AND THEY WERE WRAPPED AROUND THE INSERTER. THE DEVICE PACKAGE WAS RECEIVED IN OPEN CONDITION. WE CANNOT DETERMINE AT WHAT POINT THIS FAILURE OCCURRED. THUS, THE COMPLAINT CANNOT BE CONFIRMED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED PROBLEM CANNOT BE DETERMINED. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PART (210711), LOT (L854953) COMBINATION AND NO NON-CONFORMANCES 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).

    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. 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. H10 ADDITIONAL NARRATIVE: ADDITIONAL INFORMATION: H6: METHOD CODES: DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PART# 210711, LOT# L854953, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. UPON VISUAL OBSERVATION, THAT THE BIOCRYL ANCHOR WAS FOUND TO BE BROKEN INTO TWO PIECES AND THE BROKEN DISTAL PART WAS RETURNED AT CQ. IT WAS OBSERVED THAT THE SUTURES WERE ATTACHED TO THE ANCHOR AND THEY WERE WRAPPED AROUND THE INSERTER. THE DEVICE PACKAGE WAS RECEIVED IN OPEN CONDITION. WE CANNOT DETERMINE AT WHAT POINT THIS FAILURE OCCURRED. THUS, THE COMPLAINT CANNOT BE CONFIRMED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED PROBLEM CANNOT BE DETERMINED. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PART (210711), LOT (L854953) COMBINATION AND NO NON-CONFORMANCES 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 · 1

    PRODUCT COMPLAINT #: (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INITIAL REPORTER PHONE NUMBER: (B)(6). INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. UPON VISUAL OBSERVATION, THAT THE BIOCRYL ANCHOR WAS FOUND TO BE BROKEN INTO TWO PIECES AND THE BROKEN DISTAL PART WAS RETURNED AT CQ. IT WAS OBSERVED THAT THE SUTURES WERE ATTACHED TO THE ANCHOR AND THEY WERE WRAPPED AROUND THE INSERTER. THE DEVICE PACKAGE WAS RECEIVED IN OPEN CONDITION. WE CANNOT DETERMINE AT WHAT POINT THIS FAILURE OCCURRED. THUS, THE COMPLAINT CANNOT BE CONFIRMED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED PROBLEM CANNOT BE DETERMINED. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PART (210711), LOT (L854953) COMBINATION AND NO NON-CONFORMANCES 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 · 1

    IT WAS REPORTED BY AFFILIATE VIA PHONE THAT DURING A LABRAL REPAIR SURGERY WHEN PACKAGE OF THE LUPINE BR W/ORTHCRD WAS OPENED IT WAS NOTED THAT THE ANCHOR WAS BROKEN, AND WHEN THE VAPR S90 4.0 MM WAS GOING TO BE USED IT WAS NOT ABLE TO ABLATE AND IT DID NOT COAGULATE EITHER. THE PROCEDURE WAS COMPLETED USING OTHER DEVICES. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206627 LUPINE BR W/ORTHCRD SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 210711 L854953 10886705001095

    Patients

    Seq Age Sex Outcome Treatment
    1