BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALIX AV BR 5.5 TAPE BLUE

    MDR report key: 7934593 · Received October 4, 2018

    Report

    Report Number
    1221934-2018-54802
    Event Type
    Malfunction
    Date Received
    October 4, 2018
    Date of Event
    September 10, 2018
    Report Date
    September 10, 2018
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    MAI
    UDI-DI
    10886705027811
    PMA / PMN Number
    K170639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. ONLY THE BROKEN ANCHOR AND THE SUTURES WERE RETURNED FOR EVALUATION. VISUAL OBSERVATION REVEALED A BREAK IN THE ANCHOR MIDDLE BODY, CONFIRMING THE COMPLAINT. THE INSERTER SHAFT WAS NOT RETURNED WITH THE IMPLANT DEVICE. BOTH SUTURES WERE RETURNED, NO ANOMALIES FOUND. THE SUTURE BRIDGE WAS INTACT. AS REPORTED THE ANCHOR BROKE UPON INSERTING THE ANCHOR INTO THE PREPARED BONE HOLE. VISIBLE SURGICAL DEBRIS IS SHOWN ON THE BROKEN ANCHOR, MIDDLE SECTION. POSSIBLE ROOT CAUSE FOR THE USER TO EXPERIENCE THIS TYPE OF FAILURE COULD BE OFF AXIS INSERTION, EXCESSIVE LEVERING DURING INSERTION, USING INCORRECT INSTRUMENTATION FOR PREPARING BONE HOLE. THIS FAILURE COULD BE ATTRIBUTED TO USER TECHNIQUE. HOWEVER, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PART#: 222361 LOT#: L570380 COMBINATION AND NO NONCONFORMANCES WERE IDENTIFIED. 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 TO MONITOR THE EXTENT TO WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE CUSTOMER'S 5.5 HEALIX ADVANCE ANCHOR WITH BLUE PERMATAPE SUTURE BROKE UPON INSERTION. THE ANCHOR WAS BROKEN MIDWAY DOWN. THE ANCHOR WAS REMOVED FROM THE PATIENT WITH NO FRAGMENTS LEFT BEHIND. THE SALES REP STATED THE PATIENT HAD NORMAL BONE DENSITY. THE CASE WAS COMPLETED USING ANOTHER LIKE-DEVICE IN THE SAME BONE HOLE WITH NO PATIENT HARM OR DELAYS. THE DEVICE IS BEING RETURNED FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777935 HEALIX AV BR 5.5 TAPE BLUE SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI MEDOS INTERNATIONAL SàRL L570380 10886705027811

    Patients

    Seq Age Sex Outcome Treatment
    1