BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSALOK PEEK WITH ORTHOCORD

    MDR report key: 8604600 · Received May 13, 2019

    Report

    Report Number
    1221934-2019-57126
    Event Type
    Malfunction
    Date Received
    May 13, 2019
    Date of Event
    April 25, 2019
    Report Date
    April 25, 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

    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 REVEALED THAT THE DISTAL PORTION OF THE VERSALOK PEEK ANCHOR WAS PEELED. HENCE, PREVENTING THE DEVICE FROM ADVANCING CORRECTLY INTO THE BONE. THEREFORE, THIS COMPLAINT CAN BE CONFIRMED. WE CANNOT DETERMINE A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE. HOWEVER, GIVEN THE INFORMATION PROVIDED, IT IS POSSIBLE THAT THE DEVICE COULD HAVE BEEN USED OFF-AXIS DURING THE PROCEDURE. HENCE, CAUSING THE ANCHOR TO PEEL WHEN CONTACTING THE HARD BONE. FURTHERMORE, A NON-CONFORMANCE SEARCH WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED FOR THIS PART NUMBER (210818) LOT NUMBER (2L32153) COMBINATION. AT THIS POINT, 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

    PRODUCT COMPLAINT # (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).

    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 DISTAL PORTION OF THE ANCHOR PEELED UP AS IT WAS BEING MALLETED AND WOULD NOT ADVANCE CORRECTLY INTO THE PATIENT. THE SALES REP STATED THAT THE ANCHOR WAS REMOVED WITH NO DEBRIS LEFT BEHIND. THE PATIENT HAD HARD BONE. THE CASE WAS COMPLETED WITH ANOTHER LIKE-ANCHOR IN THE SAME BONE HOLE WITH NO PATIENT HARM OR SURGICAL DELAY. THE ANCHOR IS BEING RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398445 VERSALOK PEEK WITH ORTHOCORD SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 2L32153 10886705001323

    Patients

    Seq Age Sex Outcome Treatment
    1