BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RGDLOOP ADJUSTABLE STND

    MDR report key: 9494775 · Received December 19, 2019

    Report

    Report Number
    1221934-2019-60048
    Event Type
    Malfunction
    Date Received
    December 19, 2019
    Date of Event
    November 29, 2019
    Report Date
    December 4, 2019
    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 HEALTH CARE 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. 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: CORRECTION: D10: THE DATE DEVICE RETURNED TO MANUFACTURER WAS REPORTED AS 12/17/2019 ON THE INITIAL REPORT AND HAS BEEN UPDATED AS 2/11/2020 TO REFLECT THE CORRECT INFORMATION. DEVICE EVALUATION: INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED INCOMPLETE AT CQ. VISUAL OBSERVATION CONFIRMS THAT THE CORTICAL IMPLANT (111608) AND LEAD SUTURE (111456) WERE RECEIVED AT CQ WITHOUT ANY DAMAGE. BUT THE REPORTED LOOP PART AND TRIAL SUTURE WERE NOT RETURNED AT CQ. THUS, THE COMPLAINT CANNOT BE CONFIRMED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. AN MRE WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED FOR THIS PART (232447) - LOT NUMBER (5L23240) 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 [5L23240] NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION (ACL) SURGICAL PROCEDURE, WHEN TIGHTENING THE LOOP, THE SUTURE BROKE. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288336 RGDLOOP ADJUSTABLE STND SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE MBI MEDOS INTERNATIONAL SàRL 232447 5L23240 10886705024094

    Patients

    Seq Age Sex Outcome Treatment
    1