BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSALOK PEEK WITH ORTHOCORD

    MDR report key: 8202355 · Received December 28, 2018

    Report

    Report Number
    1221934-2018-55860
    Event Type
    Malfunction
    Date Received
    December 28, 2018
    Date of Event
    December 20, 2018
    Report Date
    January 8, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705001323
    PMA / PMN Number
    K150209
    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATION REVEALS THAT THE PROXIMAL END OF THE PEEK ANCHOR IS BROKEN. THE COMPLAINT IS CONFIRMED. AS PER PROVIDED INFORMATION SALES REPRESENTATIVE MENTIONED THAT THE PATIENT HAD HARD BONE. THE POSSIBLE ROOT CAUSE COULD BE THAT THE PEEK ANCHOR HIT THE HARD BONE WHICH LED TO THE REPORTED FAILURE. OTHER THAN ABOVE MENTIONED POSSIBILITY, WE CANNOT DISCERN ANY DEFINITE ROOT CAUSE AT THIS POINT OF TIME. NON CONFORMANCE REVIEW WAS PERFORMED, NO NONCONFORMANCES WERE IDENTIFIED FOR THIS PART NUMBER (210818), LOT NUMBER (L882974) COMBINATION. AT THIS 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. UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4). AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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 VERSALOK PEEK ANCHOR WITH ORTHOCORD BROKE AT THE DISTAL END NEAR THE METAL INSERTER WHILE INSERTING INTO THE PATIENT. THE SALES REP STATED THAT THE PATIENT HAD HARD BONE. THE ANCHOR WAS REMOVED FROM THE PATIENT BY PULLING THE SUTURES AND THE INSERTER. THE SALES REP STATED THAT NOTHING WAS LEFT IN THE PATIENT. THE CASE WAS COMPLETED WITH ANOTHER LIKE-ANCHOR IN THE SAME BONE HOLE WITH NO PATIENT HARM OR TIME DELAY. THE SALES REP STATED THAT THERE WERE NO PROCEDURAL FACTORS THAT CONTRIBUTED TO BREAKAGE, AND THERE IS NO NEED FOR SURGICAL INTERVENTION. THE ANCHOR 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
    1043791 VERSALOK PEEK WITH ORTHOCORD SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US L882974 10886705001323

    Patients

    Seq Age Sex Outcome Treatment
    1