BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PANALOK RC QA+DS SUTURE PANACRYL

    MDR report key: 6562268 · Received May 11, 2017

    Report

    Report Number
    1221934-2017-10197
    Event Type
    Injury
    Date Received
    May 11, 2017
    Date of Event
    April 11, 2017
    Report Date
    April 12, 2017
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    PMA / PMN Number
    K150209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT AVAILABLE FOR A PHYSICAL EVALUATION. ANCHOR BREAKAGES ARE TYPICALLY ASSOCIATED WITH OFF AXIS INSERTION, LEVERING DURING INSERTION, HARD BONE QUALITY OR USING INCORRECT INSTRUMENTATION FOR PREPARING BONE HOLE. 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 INCIDENT WITH NO LINK TO THIS FAILURE 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. (B)(4). ASSOCIATED MEDWATCH: 1221934-2017-10196, 1221934-2017-10198.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED VIA EMAIL DURING A ROTATOR CUFF PROCEDURE THE ANCHOR BROKE DURING INSERTION. THE SAME THING HAPPENED ON 3 ANCHORS THEN A 4TH WAS DEPLOYED SUCCESSFULLY. THIS SURGEON HAS BEEN USING THIS ANCHOR FOR MANY YEARS AND HAS NEVER HAD AN ISSUE BEFORE. CASE DELAYED BY 20 MINUTES. NO AE TO PATIENT. PATIENT OUTCOME POST SURGERY - SUCCESSFUL CUFF REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341965 PANALOK RC QA+DS SUTURE PANACRYL MITEK ANCHOR IMPALNTS MAI DEPUY MITEK 3928255

    Patients

    Seq Age Sex Outcome Treatment
    1 Other