BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTCUFF QA+ #2 ETH CP-2 *EA

    MDR report key: 8822545 · Received July 24, 2019

    Report

    Report Number
    1221934-2019-57764
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Date of Event
    June 27, 2019
    Report Date
    June 27, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    PMA / PMN Number
    K992611
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 DEVICE WAS RETURNED AND EVALUATED. UPON VISUAL EVALUATION OF THE DEVICE, IT CAN BE NOTICED THAT 2 OF 2 ANCHORS WERE DEPLOYED; HOWEVER, UNDER MAGNIFICATION IT WAS FOUND THAT THE INSERTER TIP WHERE THE ANCHOR SITS IS BROKEN; THE COMPLAINT IS CONFIRMED. THE IFU STATES: DO NOT TWIST OR APPLY BENDING FORCE TO THE INSERTER AS EITHER MAY DAMAGE THE ANCHOR, SUTURE OR INSERTER TIP; THEREFORE A POTENTIAL ROOT CAUSE FOR THE REPORTED EVENT COULD BE ATTRIBUTED TO EXCESSIVE FORCE APPLIED WHILE OPERATING THE INSTRUMENT. HOWEVER, WE CANNOT DETERMINE A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT. A NON-CONFORMANCE SEARCH WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED FOR THIS PART NUMBER (212031) WITH LOT NUMBER (3L87466 ) COMBINATION PER QLIK SEARCH PERFORMED ON 7/1/2019. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY 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 SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. D10: DEVICE RETURNED. H3, H6: THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING 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.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE VIA E-MAIL THAT THE CUSTOMER REPORTS THAT DURING A LEFT SHOULDER ARTHROSCOPY, ONLY 3 OF THE 4 ROTCUFF QA+ ANCHORS WERE IMPLANTED. TWO ANCHORS WERE DEFECTIVE BUT ONE OF THE DEFECTIVE ANCHORS WAS IMPLANTED. ALL FOUR ANCHORS HAVE THE SAME LOT NUMBER. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE DEVICES MALFUNCTIONED AND APPEARED TO BE BENT AND BROKEN. IT WAS ALSO REPORTED THE PROCEDURE WAS COMPLETED BY USING 3 ANCHORS WHICH WERE PLACED INSTEAD OF 4; THE 3 ANCHORS WERE IMPLANTED BY IMPACTION, WITHOUT A PRE- HOLE. THE AFFILIATE ALSO REPORTED THERE WAS A 5 MINUTE SURGICAL DELAY DUE TO THE REPORTED MALFUNCTION AND THERE ARE NO KNOWN PATIENT CONSEQUENCES. THE DEVICES WERE REQUESTED FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616971 ROTCUFF QA+ #2 ETH CP-2 *EA SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE HWC DEPUY MITEK LLC US 3L87466

    Patients

    Seq Age Sex Outcome Treatment
    1