BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RGDLOOP ADJUSTABLE LONG

    MDR report key: 7550451 · Received May 29, 2018

    Report

    Report Number
    1221934-2018-50991
    Event Type
    Malfunction
    Date Received
    May 29, 2018
    Date of Event
    April 1, 2018
    Report Date
    April 28, 2018
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    MBI
    UDI-DI
    10886705024100
    PMA / PMN Number
    K140324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. CORRECTION: MANUFACTURER NAME, CITY AND STATE, MFR SITE-REPORT SOURCE: THE MANUFACTURER CONTACT NAME HAS BEEN UPDATED AS KARA DITTY-BOVARD. CONTACT PHONE NUMBER AND EMAIL ADDRESS HAVE BEEN UPDATED ACCORDINGLY. THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS DISCARDED BY THE CUSTOMER, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PART (232448) AND LOT (L393510) COMBINATION AND NO NON-CONFORMANCES WERE IDENTIFIED. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. IF ANY ADDITIONAL INFORMATION IS OBTAINED, THIS COMPLAINT WILL BE RE-OPENED TO CAPTURE THAT INFORMATION. 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.

    Additional Manufacturer Narrative · 1

    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

    EVENT: AFTER POSITIONING THE ADJUSTABLE RIGIDLOOP PLATE ON THE LATERAL CORTEX OF THE FEMUR, AND AS INDICATED IN THE MANUAL, PROCEED TO ADJUST THE GRAFT THROUGH THE WHITE LOOP, BEFORE IT IS BLOCKED, THE THREAD BREAKS, WITH WHICH THE SYSTEM WAS NOT FINISHED ADJUSTING AND CONSEQUENTLY THE GRAFT IS RETURNED. NO PATIENT CONSEQUENCES. ACTION TAKEN FOR PROCEDURE: THE IMPLANT THAT FAILED IS REMOVED AND A NEW ONE IS USED. ACCOUNT NAME WAS NOT INFORMED. (B)(4), LOT: L393510. ADDITIONAL INFORMATION: THE SALES REP INFORMED US: (B)(6). THE PATIENT DID NOT SUFFER ANY SERIOUS OR PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393143 RGDLOOP ADJUSTABLE LONG SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE MBI MEDOS INTERNATIONAL SàRL L393510 10886705024100

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR