BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5 HEALIX ADVANCE PEEK ANCHOR W/ PERMACORD

    MDR report key: 6272097 · Received January 24, 2017

    Report

    Report Number
    1221934-2017-10034
    Event Type
    Injury
    Date Received
    January 24, 2017
    Date of Event
    November 21, 2016
    Report Date
    November 21, 2016
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    PMA / PMN Number
    K133794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT AVAILABLE FOR A PHYSICAL EVALUATION. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. A DHR REVIEW HAS BEEN CONDUCTED AND THE RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITH AN UNRELATED NC WITH NO LINK TO THIS COMPLAINT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY (B)(4) COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, SHOULD ANY NEW INFORMATION BE PROVIDED IN FUTURE, THIS FILE WILL BE RE-OPENED AND A THOROUGH INVESTIGATION WILL BE PERFORMED. DEPUY (B)(4) 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: (01)10886705024766(10)3759848(17)170228 ASSOCIATED MEDWATCH: 1221934-2016-10565 THIS IS THE MEDWATCH FOR SECOND DEVICE IN THIS COMPLAINT.

    Description of Event or Problem · 1

    THE SALES REP REPORTED VIA PHONE A PATIENT THAT RECEIVED A ROTATOR CUFF REPAIR 1 YEAR PRIOR WAS EXPERIENCING PAIN. DURING THE REVISION OF THE PROCEDURE THE SURGEON FOUND THAT THE 5.5 HEALIX ADVANCE W/ PERMACORD PEEK WAS JUST SITTING LOOSELY IN THE BONE HOLE AND NO LONGER ENGAGED IN THE BONE HOLE. THE SURGEON HAD TO REMOVE THE ANCHORS, CREATE NEW BONE HOLES AND REPLACE THEM WITH COMPETITOR ANCHORS. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS DURING THE REVISION. THE SALES REP STATED THAT THE DEVICE WOULD NOT BE RETURNED AS THEY WERE DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57346 5.5 HEALIX ADVANCE PEEK ANCHOR W/ PERMACORD MITEK ANCHOR IMPLANTS MAI DEPUY MITEK 3759848

    Patients

    Seq Age Sex Outcome Treatment
    1 Other