BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5 HEALIX ADVANCE BR ANCHOR W/ ORTHOCORD AND NEEDLES

    MDR report key: 7502091 · Received May 10, 2018

    Report

    Report Number
    1221934-2018-50616
    Event Type
    Malfunction
    Date Received
    May 10, 2018
    Report Date
    April 12, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705021352
    PMA / PMN Number
    K120078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH 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. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS DISCARDED BY THE CUSTOMER THEREFORE, DEVICE IS NOT AVAILABLE FOR A PHYSICAL EVALUATION. PICTURES WERE NOT PROVIDED. THIS COMPLAINT IS NOT CONFIRMED. IT WAS REPORTED THAT THE IMPLANT BROKE DURING INSERTION. IT WAS NOTED THE DISTAL TIP OF THE ANCHOR BROKE. 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: 1221934-2018-50615.

    Additional Manufacturer Narrative · 1

    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. UDI: (B)(4) -INCOMPLETE. THE EXPIRATION DATE IS NOT CURRENTLY AVAILABLE. ASSOCIATED MEDWATCH: 1221934-2018-50615.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT TWO ANCHORS TIPS SNAPPED - 1 X 222295 (L513089) AND 1 X 222299 (L421857). THE TIP OF THE 222299 REMAINED IN THE PATIENT. THE FAILURE COULD BE DUE TO BONE QUALITY (EXTREMELY GOOD AND STRONG) OR THE ANGLE OF THE ANCHOR GOING IN. IT WAS UNCLEAR. THE CASE WAS COMPLETED AS THE NEXT ANCHOR STAYED IN FINE. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION PROVIDED BY THE REP VIA E-MAIL ON 5-8-2018: THE DELAY WAS LESS THAN 30 MINUTES AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE TIP BROKE OFF IN THE PATIENT AND WAS LEFT THERE. AS PREVIOUSLY STATED, THE TIP OF ONE OF THE ANCHORS WAS LEFT IN THE PATIENT. THAT WAS THE ONLY FRAGMENT. IT WAS A CLEAN SNAP OFF THE ANCHOR AND NO PIECES NEEDED TO BE RETRIEVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ANCHOR. THE SURGEON SWITCHED FROM THE OLDER GENERATION HEALIX AWL TO THE NEWER HEALIX ADVANCE AWL TO FINISH THE PROCEDURE AS THE ANCHORS SEEMED TO BE DOING BETTER THAN WAY. THERE WERE MULTIPLE ALTERNATIVES AVAILABLE TO THE SURGEON. NO INTERVENTION IS PLANNED AS THE SURGERY WAS A SUCCESS. THE SAME BONE HOLE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT AS THE SURGERY WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346981 5.5 HEALIX ADVANCE BR ANCHOR W/ ORTHOCORD AND NEEDLES SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US L421857 10886705021352

    Patients

    Seq Age Sex Outcome Treatment
    1