BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5 HEALIX ADVANCE PEEK W/CORD

    MDR report key: 8284325 · Received January 29, 2019

    Report

    Report Number
    1221934-2019-56188
    Event Type
    Malfunction
    Date Received
    January 29, 2019
    Date of Event
    September 29, 2016
    Report Date
    September 29, 2016
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    UDI-DI
    10886705021390
    PMA / PMN Number
    K120449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED FAILURE MODE. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. 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. NO NONCONFORMANCES WERE IDENTIFIED FOR THIS PRODUCT CODE 222303 - LOT # 3894912 COMBINATION. REVIEW CONDUCTED PER (B)(4). THIS REPORT IS BEING FILED FROM THE ETQ COMPLAINT MANAGEMENT SYSTEM AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS. UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA PHONE THAT DURING A ROTATOR CUFF REPAIR THE SUTURE BRIDGE ON THE CUSTOMER'S 4.5 HEALIX ADVANCE PEEK WITH CORD BROKE AFTER INSERTION. THE ANCHOR ALONG WITH PIECES AND DEBRIS WERE REMOVED FROM THE PATIENT WITH NO DEBRIS LEFT IN THE PATIENT. THE CASE WAS COMPLETED BY WITH A 6.5 ANCHOR USING THE SAME BONE HOLE. THERE WERE NO PATIENT CONSEQUENCES BUT THERE WAS A 15 MINUTE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79253 4.5 HEALIX ADVANCE PEEK W/CORD SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE HWC DEPUY MITEK LLC US 3894912 10886705021390

    Patients

    Seq Age Sex Outcome Treatment
    1