BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALIX AV BR 5.5 TAPE BLUE

    MDR report key: 7899040 · Received September 21, 2018

    Report

    Report Number
    1221934-2018-54721
    Event Type
    Malfunction
    Date Received
    September 21, 2018
    Date of Event
    August 24, 2018
    Report Date
    August 24, 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 · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATION CONFIRMS THE DISTAL TIP OF THE ANCHOR IS BROKEN, SEPARATED FROM THE INSERTER AND THE SUTURE WAS NOT RETURNED. THE COMPLAINT CAN BE CONFIRMED. THIS TYPE OF ANCHOR BREAKAGE IS CONSISTENT WITH BREAKAGE CAUSED BY THE COMBINATION OF TORQUE AND BENDING, A USER TECHNIQUE ISSUE BUT OTHER THAN THIS POSSIBILITY, WE CANNOT DISCERN A DEFINITIVE ROOT CAUSE FOR THIS FAILURE. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PART 222361, LOT L570380 COMBINATION AND NO NON-CONFORMANCE'S WERE IDENTIFIED. 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 REPORT NUMBER: 1221934-2018-54722.

    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. (B)(4). ASSOCIATED MEDWATCH: 1221934-2018-54722.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE SALES REP'S 5.5 HEALIX ADVANCE ANCHOR WITH PERMATAPE BLUE BROKE INTO TWO PIECES WHEN IT WAS BEING INSERTED WITHOUT A TRIAL. THEY THEN USED THE SALES REP'S 5.5 HEALIX ADVANCE ANCHOR WITH PERMATAPE WHITE/BLUE, WHICH ALSO BROKE INTO TWO PIECES UPON INSERTION WITH A TRIAL. THE CASE WAS COMPLETED BY USING THE PERMATAPE FROM THE SECOND ANCHOR WITH NO PATIENT HARM, BUT THERE WAS A FIVE MINUTE DELAY TO OPEN ANOTHER ANCHOR. THE SALES REP STATED THEY DID NOT NEED TO CREATE ANOTHER BONE HOLE, THERE WERE NO DEBRIS LEFT IN THE PATIENT, OR ANY ABNORMAL PROCEDURAL OR ANATOMICAL FACTORS. THE DEVICES ARE BEING RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740248 HEALIX AV BR 5.5 TAPE BLUE SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI MEDOS INTERNATIONAL SàRL L570380 10886705027811

    Patients

    Seq Age Sex Outcome Treatment
    1