BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUPINE BR DS W/ORTHCRD

    MDR report key: 8879055 · Received August 9, 2019

    Report

    Report Number
    1221934-2019-57951
    Event Type
    Malfunction
    Date Received
    August 9, 2019
    Date of Event
    July 16, 2019
    Report Date
    July 16, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705001101
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY THE COMPLAINT DEVICES WERE RECEIVED AND INSPECTED.WE HAVE RECEIVED 6-LUPINE BR DS W/ORTHCRD. THE COMPLAINT CAN BE CONFIRMED. IT WAS OBSERVED THAT THE ANCHORS WERE ATTACHED TO THE INSERTER VIA THE TENSIONED SUTURES, AND WAS DEFORMED.THE PROBABLE ROOT CAUSE OF THIS FAILURE IS THAT THE DEVICE WAS EXPOSED TO AN ELEVATED TEMPERATURE BEFORE IT WAS OPENED IN THE OPERATING ROOM PRIOR TO SURGERY. THE ELEVATED TEMPERATURE AND THE SLIGHT TENSION ON THE SUTURE COULD RESULT IN THE BENDING OF THE ANCHOR. IN THE MANUFACTURING PROCESS THERE IS A 100% VERIFICATION IN THE ASSEMBLY STEP FOR SUTURE TENSION DONE BY THE OPERATORS. THEN A SAMPLING INSPECTION OF 13 UNITS IS DONE BY A CERTIFIED OPERATOR OUTSIDE THE PRODUCTION LINE. NO FURTHER INFORMATION REGARDING THE CAUSE OF THE DEFECT HAS BEEN PROVIDED TO HELP DETERMINE A ROOT CAUSE FOR THIS FAILURE.A NON-CONFORMANCE SEARCH WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED FOR THIS PART NUMBER (210712) WITH LOT NUMBER (L991841 ) COMBINATION PER QLINK SEARCH PERFORMED ON 09/11/2019. 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. DEVICE HISTORY LOT A NON-CONFORMANCE SEARCH WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED FOR THIS PART NUMBER (210712) WITH LOT NUMBER (L991841 ) COMBINATION PER QLINK SEARCH PERFORMED ON 09/11/2019. 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

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER PROCEDURE WHEN THEY OPENED SIX OF THEIR LUPINE LOOP RAPIDE ANCHORS WITH ORTHOCORD DUAL SUTURE ON THE BACK TABLE, IT WAS FOUND THAT THE ANCHORS ARE BENT AND APPEAR TO BE MELTED. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR'S DEVICE WITH NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THE SALES REP STATED WHEN SHE ASKED HER ASSOCIATE REP WHERE HE HAD KEPT THE DEVICES PRIOR TO BRINGING THEM TO THE FACILITY, HE STATED IN HIS GARAGE AND THAT HIS GARAGE WASN'T HOT. THE SALES REP STATED THAT THE DEVICES WERE NOT USED ON THE PATIENT. THE DEVICES WILL BE RETURNING FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671733 LUPINE BR DS W/ORTHCRD SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US L991841 10886705001101

    Patients

    Seq Age Sex Outcome Treatment
    1