BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5 HEALIX PEEK ANCH.W/OCORD

    MDR report key: 11179089 · Received January 15, 2021

    Report

    Report Number
    1221934-2021-00132
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    December 30, 2020
    Report Date
    December 30, 2020
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705007530
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, 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. D9, H3, H6: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR TH INIILED AS APPRTCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: D4, H4: THE EXPIRATION AND MANUFACTURE DATE WERE REPORTED AS UNKNOWN ON THE INITIAL REPORT. BOTH FIELDS HAVE BEEN UPDATED ACCORDINGLY. THEREFORE, UDI: (01)10886705007530(10)7L20765(17)230731. INVESTIGATION SUMMARY ==> ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT DURING THE SURGERY OF ROTATOR CUFF REPAIR SURGERY, THE ANCHOR WAS BROKEN OFF, REMOVED ALL THE PIECES. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. THE DEVICE HAS THE ANCHOR ATTACHED TO ITS TIP; THE ANCHOR IS BROKEN IN TWO PIECES. THE HANDLE COVER WAS REMOVED TO VERIFY THE SUTURES INTEGRITY, THEY ARE IN GOOD CONDITION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 7L20765 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. AS PART OF DEPUY SYNTHES MITEK QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ACCORDING WITH THE VISUAL INSPECTION RESULT, THIS COMPLAINT CAN BE CONFIRMED. THE POSSIBLE ROOT CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO AXIAL MISALIGNMENT DURING INSERTION, HARD BONE QUALITY OR USING INCORRECT INSTRUMENTATION FOR PREPARING BONE HOLE, AS PER THE IFU 109139: INSERTING THE AWL OR DRILL TO LESS THAN THE SPECIFIED DEPTH, AXIAL MISALIGNMENT OR LEVERING WITH THE ANCHOR UPON INSERTION MAY RESULT IN ANCHOR FRACTURE. DO NOT APPLY A BENDING FORCE TO THE INSERTER. THIS CAN DAMAGE THE ANCHOR OR INSERTER TIP. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO MONITOR ADDITIONAL COMPLAINT INFORMATION FOR POTENTIAL SAFETY SIGNALS THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). THE EXPIRATION DATE IS CURRENTLY UNAVAILABLE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE ANCHOR WAS BROKEN OFF INTO TWO PIECES. ALL THE PIECES WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77625 4.5 HEALIX PEEK ANCH.W/OCORD SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 222205 7L20765 10886705007530

    Patients

    Seq Age Sex Outcome Treatment
    1