BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RGDLOOP ADJUSTABLE STND

    MDR report key: 9624052 · Received January 23, 2020

    Report

    Report Number
    1221934-2020-00287
    Event Type
    Malfunction
    Date Received
    January 23, 2020
    Date of Event
    January 7, 2020
    Report Date
    January 14, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    MBI
    UDI-DI
    10886705024094
    PMA / PMN Number
    K140324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. 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. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED INCOMPLETE AT CQ. VISUAL OBSERVATION CONFIRMS THAT THE CORTICAL IMPLANT (111608), TRIAL SUTURE (102835), AND LEAD SUTURE (111456) WERE RECEIVED AT CQ WITHOUT ANY DAMAGE. BUT THE SUTURE SPLICE (111860) GOT BROKEN AND FRAYED AT THE BROKEN ENDS. THE BROKEN PART OF THE SUTURE SPLICE WAS RETURNED AT CQ. THUS, THE COMPLAINT CAN BE CONFIRMED. THE SUTURE MIGHT HAVE GOT BROKEN AND FRAYED DUE TO HIGH TENSION WHILE TIGHTENING DURING THE PROCEDURE. AN MRE WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED FOR THIS PART (232447) - LOT NUMBER (5L45066) COMBINATION. 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. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT/SERIAL NUMBER (B)(6), AND NO NON-CONFORMANCES WERE IDENTIFIED.

    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. 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. H10 ADDITIONAL NARRATIVE: D10, 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 · 1

    PRODUCT COMPLAINT # (B)(4). 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)(6). UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE VIA PHONE THAT DURING AND ACL RECONSTRUCTION, BEFORE TIGHTEN THE SUTURE, THE RGDLOOP ADJUSTABLE STND WAS BROKEN AS IT SHOWS IN THE PHOTO. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83434 RGDLOOP ADJUSTABLE STND SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE MBI MEDOS INTERNATIONAL SàRL 232447 5L45066 10886705024094

    Patients

    Seq Age Sex Outcome Treatment
    1