BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUESPAN 12 DEGREE PEEK

    MDR report key: 7848061 · Received September 5, 2018

    Report

    Report Number
    1221934-2018-54597
    Event Type
    Malfunction
    Date Received
    September 5, 2018
    Date of Event
    August 3, 2018
    Report Date
    August 3, 2018
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    MBI
    UDI-DI
    10886705026012
    PMA / PMN Number
    K153667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED WITH NEW PRODUCT DEVELOPMENT (NPD). AS REPORTED THE 12-DEGREE NEEDLE BROKE OFF FROM THE DEVICE. THIS COMPLAINT IS CONFIRMED. THE IMPLANTS WERE NOT RETURNED WITH THE DEVICE. VIA FUNCTIONAL TESTING OF THE RED TRIGGER MULTIPLE TIMES THE PUSHER ROD WAS ABLE TO PASS THROUGH THE SHAFT AS EXPECTED, HOWEVER WAS SCRAPPING THE INNER SHAFT. NPD INVESTIGATED THE DEVICE AND DETERMINED THAT THE USER COULD HAVE OVER PENETRATED THE NEEDLE IN THE MENISCUS, (WHICH ALSO PUSHED THE SILICONE SLEEVE BACK), AND THE NEEDLE GOT CAUGHT, WITH THE COMBINATION OF LEVERING THE DEVICE, THE NEEDLE SNAPPED OFF. THIS FAILURE COULD BE ATTRIBUTED TO USER TECHNIQUE; HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PART 228151 LOT L595149 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. (B)(4).

    Additional Manufacturer Narrative · 0

    (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. 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 · 0

    ADDITION INFORMATION RECEIVED FROM AFFILIATE ON (B)(6) 2018: THE NEEDLE WAS A 12 DEGREE NEEDLE. IT IS UNKNOWN IF THE SURGEON USED A PROBE, FULLY DEPRESSED THE TRIGGER, IF THE NEEDLE WAS STILL IN THE SCOPE VIEW, IF THE SURGEON PENETRATED THE MENISCUS ALL THE WAY TO THE DEPTH STOP, IF THE FAILURE OCCURRED WITH THE FIRST OR SECOND IMPLANT, WHAT THE PATIENT¿S BONE QUALITY WAS, IF THE SURGEON WAS OFF AXIS, IF THE SAME BONE HOLE WAS USED TO COMPLETE THE PROCEDURE, THE LOCATION AND TYPE OF REPAIR, OR IF THE REPAIR COMPLETED BY ANOTHER COMPETITIVE DEVICE, INSIDE OUT TECHNIQUE, OR PARTIAL MENISCECTOMY. IT WAS NOTED THE IMPLANT BROKE INTO TWO (2) PIECES ON ITS NEEDLE PART; THE BROKEN PART OF THE IMPLANT WAS REMOVED FROM THE PATIENT.

    Additional Manufacturer Narrative · 1

    (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 AN AFFILIATE THAT THE NEEDLE TIP WAS BROKEN AND BEING STUCK IN THE MENISCUS. THE SURGEON SUCCESSFULLY REMOVED THE BROKEN NEEDLE, SO THAT THERE WERE NO BROKEN PARTS IN THE PATIENT¿S BODY. THE SURGERY WAS FINISHED WITHOUT ANY OTHER PROBLEM ALTHOUGH IT WAS NOT REPORTED HOW THE SURGERY WAS COMPLETED. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS LESS THAN 30 MINUTE SURGICAL DELAY AND NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686590 TRUESPAN 12 DEGREE PEEK SOFT-TISSUE ANCHOR, BIOABSORBABLE MBI MEDOS INTERNATIONAL SARL L595149 10886705026012

    Patients

    Seq Age Sex Outcome Treatment
    1