BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5MM HEALIX PEEK 3-SUTURE ANCHOR W/ORTHOCORD

    MDR report key: 7856570 · Received September 7, 2018

    Report

    Report Number
    1221934-2018-54613
    Event Type
    Malfunction
    Date Received
    September 7, 2018
    Date of Event
    August 9, 2018
    Report Date
    August 10, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705007554
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. THE EXP DATE WAS REPORTED AS UNKNOWN IN THE INITIAL REPORT AND HAS BEEN UPDATED AS 1/31/2021; THEREFORE, UDI: (B)(4). INVESTIGATION SUMMARY: THE DEVICE WAS RECEIVED AND EVALUATED WITH NPD. BOTH THE SUTURE CARD AND THE SUTURE COVER WERE NOT RETURNED FOR EVALUATION. AS REPORTED THE IMPLANT FAILED TO RELEASE FROM THE INSERTER SHAFT. VISUAL OBSERVATION, SHOWS NO ANOMALIES WITH THE IMPLANT OR THE INSERTER SHAFT. THE SUTURES WERE INTACT. UPON FURTHER OBSERVATION REVEALED A DEFORMED/FLATTEN ANCHOR THREADS FROM THE BASE OF THE ANCHOR, INDICATING POSSIBLE BLUNT FORCE IMPACT OR THE IMPLANT WAS PRESSED AGAINST A HARD SURFACE. NPD WAS ABLE TO REMOVE THE IMPLANT AND STATED THERE WAS AN UNUSUAL TIGHT FIT. THE SUTURES WERE REMOVED FROM THE IMPLANT. WITH THE IMPLANT ALONE, THE IMPLANT WAS REPLACED WITH THE INSERTER, NO ISSUES FOUND, CONFIRMING NO DIMENSIONAL PROBLEMS WITH THE IMPLANT OR THE DISTAL TIP OF THE INSERTER. POSSIBLE ROOT CAUSE FOR THE USER TO EXPERIENCE THIS TYPE OF FAILURE COULD BE EXCESSIVE SUTURE PULLING AT AN ANGLE WHICH COULD DISRUPT THE POSITIONING OF THE SUTURES WITH IN THE ANCHOR, RESULTING IN DIFFICULTY IN IMPLANT RELEASING FROM THE INSERTER SHAFT. 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#: 222207 LOT#: L705575 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 AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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. (B)(4). DATE OF EXPIRY CURRENTLY UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ANCHOR COULD NOT DETACH. THE ANCHOR COULD NOT DETACH FROM SHAFT IN REPAIR OF ROTATOR CUFF. CHANGED NEW ONE TO COMPLETE. THERE WAS NO ADVERSE EVENT ON PATIENT REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698022 5.5MM HEALIX PEEK 3-SUTURE ANCHOR W/ORTHOCORD SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US L705575 10886705007554

    Patients

    Seq Age Sex Outcome Treatment
    1