BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RGDLOOP ADJUSTABLE STND

    MDR report key: 8358496 · Received February 21, 2019

    Report

    Report Number
    1221934-2019-56460
    Event Type
    Malfunction
    Date Received
    February 21, 2019
    Date of Event
    January 22, 2019
    Report Date
    January 28, 2019
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    MBI
    UDI-DI
    10886705024094
    PMA / PMN Number
    K140324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AND INSPECTED. THE COMPLAINT CAN BE CONFIRMED. IT WAS OBSERVED THAT THE WHITE SUTURE WAS BROKEN. A NEW PRODUCT DEVELOPMENT (NPD) ENGINEER WAS CONSULTED FOR FURTHER INSIGHT INTO THE FAILURE. IT WAS REPORTED THAT THE SURGEON USED FORCEPS TO WRAP THE SUTURE AND THEN PULL THE SUTURE. THE NPD ENGINEER INDICATED THAT WITH CERTAIN TYPES OF FORCEPS CAN CAUSE A HIGH STRESS POINT ON THE SUTURE WHEN WRAPPED ON THE INSTRUMENT. THIS ALSO ALLOWS THE SURGEON TO PULL THE SUTURE WITH GREATER AMOUNTS OF FORCE. THEREFORE, A POTENTIAL ROOT CAUSE FOR THE SUTURE BREAKAGE COULD BE ATTRIBUTED TO THE COMBINATION OF THE FORCEPS CAUSING A STRESS POINT ON THE SUTURE WHICH MAY HAVE ALLOWED THE SURGEON TO APPLY EXCESSIVE TENSION TO THE SUTURE WHICH CAUSED IT TO BREAK. HOWEVER, GIVEN THE INFORMATION PROVIDED WE CANNOT DISCERN A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE. A NON-CONFORMANCE SEARCH WAS CONDUCTED TO INVESTIGATE ANY DEFECTS IDENTIFIED DURING PRODUCTION THAT MAY CONTRIBUTE TO THE COMPLAINT CONDITION. NO NON-CONFORMANCE WAS IDENTIFIED FOR THIS PART-LOT NUMBER 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. THE INCORRECT DATE WAS INADVERTENTLY UTILIZED IN INITIAL MEDWATCH. THE CORRECT DATE IS JANUARY 27, 2019.  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.

    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 AFFILIATE VIA THE CST TOOL THAT DURING A KNEE ARTHROSCOPY WHEN THE SURGEON PASSED THE THREAD AND REDUCED THE EYELET OF THE ADJUSTABLE RIGIDLOOP THE THREAD BURST. THE PROCEDURE WAS COMPLETED BY USING A SECOND DEVICE WITHOUT ANY PATIENT HARM. THE AFFILIATE DID, HOWEVER, REPORT AN APPROXIMATE TIME DELAY OF 6 MINUTES. THE IMPLANT WAS RETURNED TO A WAREHOUSE. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE ON 02/06/2019 REPORTED THAT THE SUTURE BROKE INSIDE THE JOINT SPACE. THE AFFILIATE REPORTED THAT THE SURGEON USES A HEMOSTATIC FORCEPS TO PULL, WRAPS THE SUTURE OVER THE CLAMP AND PULLS WHILE USING THE SUTURE. IT WAS REPORTED THAT ANOTHER IMPLANT WAS REQUIRED, TOUCHED SKIN AND MUSCLE A LITTLE BUT IT WAS EASY TO REMOVE IT. THE AFFILIATE ALSO STATED THAT THE DEVICE WOULD BE RETURNING FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153347 RGDLOOP ADJUSTABLE STND SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE MBI MEDOS INTERNATIONAL SARL L982456 10886705024094

    Patients

    Seq Age Sex Outcome Treatment
    1