BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5 HEALIX BR ANCHOR W/OCORD

    MDR report key: 7494809 · Received May 8, 2018

    Report

    Report Number
    1221934-2018-50589
    Event Type
    Malfunction
    Date Received
    May 8, 2018
    Report Date
    October 5, 2017
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705007844
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE IS UNAVAILABLE FOR A PHYSICAL EVALUATION. A DHR REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT AN NR WAS OPENED RELATING TO "DURING ACTIVE AERATION PHASE, PARAMETER N°35 "DEC MINIMUM NUMBER OF PULSES" SHOULD BE OF A MINIMUM OF 3 PULSES. IN CYCLE 17-0578-3, THE DEC NUMBER OF PULSES WAS OF 1 ONLY" WITH NO LINK WITH THIS COMPLAINT. THEREFORE, WE CANNOT DETERMINE WHAT CAUSED THE USER TO EXPERIENCE THE REPORTED EVENT, WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED FAILURE MODE. A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED TWO SIMILAR COMPLAINTS FOR THIS LOT OF DEVICES. 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. UDI: (B)(4). ASSOCIATED MEDWATCH: 1221934-2018-50590.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED VIA EMAIL THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE ONCE THE ANCHORS FIXED, THE THREAD BROKE. PER ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE ON 10-26-2017: THE PROCEDURE WAS A SHOULDER ARTHROSCOPY. THE ISSUE WAS DETECTED DURING USE. THERE WAS A 10 MINUTE DELAY IN THE PROCEDURE. THE PROCEDURE WAS ABLE TO BE COMPLETED. THE SUTURE BROKE WHEN TIGHTENING THE KNOT. THE SUTURE WAS NOT IN CONTACT WITH AN INSTRUMENT DURING BREAKAGE. A SUTURE CUTTER WAS NOT USED. PER ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE ON 11-17-2017: THE PROCEDURE WAS COMPLETED WITH THE ANCHOR. THE ANCHOR WAS NOT REMOVED. THE ORIGINAL BONE HOLE WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336850 6.5 HEALIX BR ANCHOR W/OCORD SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US L431784 10886705007844

    Patients

    Seq Age Sex Outcome Treatment
    1