BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.75MM HEALIX ADVANCE KNOTLESS BR ANCHOR

    MDR report key: 7053338 · Received November 22, 2017

    Report

    Report Number
    1221934-2017-50005
    Event Type
    Malfunction
    Date Received
    November 22, 2017
    Date of Event
    October 26, 2017
    Report Date
    May 9, 2018
    Manufacturer
    MITEK : MEDOS INTERNATIONAL SÃ RL
    Product Code
    MAI
    PMA / PMN Number
    K130917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). THE EXPIRATION DATE IS CURRENTLY UNAVAILABLE. ASSOCIATED (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS DISCARDED BY THE CUSTOMER THEREFORE, DEVICE IS NOT AVAILABLE FOR A PHYSICAL EVALUATION. NO PICTURES WERE PROVIDED. THIS COMPLAINT IS NOT CONFIRMED. IT WAS REPORTED THAT THE IMPLANTS BROKE DURING INSERTION IN THE SAME BONE HOLE. A BIGGER IMPLANT 5.5 MM ANCHOR (P/N: 222331) WAS USED TO COMPLETE THE PROCEDURE IN THE SAME BONE HOLE. NO FURTHER INFORMATION REGARDING THE PROCEDURE OR THE DEVICE USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. THE DHR REVIEW INDICATED THAT THIS BATCH OF DEVICES WERE PROCESSED WITHOUT INCIDENT, THEREFORE, THERE IS NO EVIDENCE OF MANUFACTURING ANOMALIES ON THE RECORDS REVIEWED. A REVIEW INTO THE DEPUY MITEK COMPLAINTS SYSTEM REVEALED NO COMPLAINTS OF ANY TYPE FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. BASED ON THE INFORMATION AVAILABLE THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. HOWEVER, IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. 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). ASSOCIATED MEDWATCH [MR#1221934-2017-50004].

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 SCREWS WERE BROKEN IN THE SAME BONE HOLE WHEN THE SURGEON TRIED TO INSERT THE ANCHOR BY FOLLOWING THE INSTRUCTION MANUAL DURING ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2017. THE SURGERY WAS COMPLETED BY USING ALTERNATIVE 5.5 MM ANCHOR (P/N: 222331, LOT NUMBER WAS UNKNOWN). IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS SURGICAL DELAY IN 10 MIN AND NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 SCREWS WERE BROKEN IN THE SAME BONE HOLE WHEN THE SURGEON TRIED TO INSERT THE ANCHOR BY FOLLOWING THE INSTRUCTION MANUAL DURING ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2017. THE SURGERY WAS COMPLETED BY USING ALTERNATIVE 5.5 MM ANCHOR (P/N: 222331, LOT NUMBER WAS UNKNOWN). IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS SURGICAL DELAY IN 10 MIN AND NO HARM TO THE PATIENT. ADDITIONAL INFORMATION FROM AFFILIATE: IF BREAKAGE OCCURRED NEAR SURGICAL SITE, HOW WERE FRAGMENTS RETRIEVED? NO FURTHER INFORMATION. WERE ALTERNATIVES READILY AVAILABLE? YES. WERE THERE ANY PROCEDURAL OR PATIENT ANATOMY FACTORS WHICH MAY HAVE CONTRIBUTED TO THE BREAKAGE? NO. DID ANY PORTION OF THE DEVICE REMAIN IN THE PATIENT? NO. WHERE ON THE IMPLANT DID IT BREAK? IN THE BONE HOLE. WHAT WAS THE PATIENT¿S BONE QUALITY? NO FURTHER INFORMATION. WAS THE INSERTION OFF AXIS? NO FURTHER INFORMATION. WAS THE SAME BONE HOLE USED TO COMPLETE THE PROCEDURE? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832694 4.75MM HEALIX ADVANCE KNOTLESS BR ANCHOR SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI MITEK : MEDOS INTERNATIONAL SÃ RL L436420

    Patients

    Seq Age Sex Outcome Treatment
    1