BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RGDLOOP ADJUSTABLE STND

    MDR report key: 8235209 · Received January 10, 2019

    Report

    Report Number
    1221934-2019-55965
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Date of Event
    January 6, 2019
    Report Date
    January 8, 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

    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 PHOTOGRAPHIC EVIDENCE WAS PROVIDED TO AID IN THE INVESTIGATION. THE COMPLAINT CAN BE CONFIRMED. THERE WERE NO DEFECTS OBSERVED WITH THE ACTUAL PRODUCT. SINCE THE ALLEGED DEFECT WAS AGAINST THE PACKAGING ONLY, THE INVESTIGATION FOCUSED ON THE PHOTOGRAPHIC EVIDENCE AVAILABLE. IT WAS OBSERVED FROM THE PHOTO THAT THE MITEK PRODUCED SEAL WAS NON-EXISTENT OR LACKING. A MANUFACTURING INVESTIGATION WAS INITIATED TO PROVIDE FURTHER INSIGHT INTO THIS FAILURE. A COMPLAINT REVIEW WAS CONDUCTED FOR ALL COMPLAINTS RECEIVED OVER THE PAST 2 YEARS, AND ONLY 2 OTHER COMPLAINTS WERE FOUND ALLEGING THAT THE PACKAGING WAS NOT SEALED. THE ROOT CAUSE IS MOST LIKELY ATTRIBUTABLE TO HUMAN ERROR AND LACK OF ATTENTION DURING THE SEAL INSPECTION STEP, THEREFORE AN AWARENESS TRAINING WAS PERFORMED FOR THE OPERATORS THAT WORKED ON THIS LOT OF PRODUCT. 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. A NON-CONFORMANCE (NR-0122201) WAS ISSUED TO FURTHER INVESTIGATE THE OBSERVED FAILURE MODE. AT THIS POINT, 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 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 · 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. 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 ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY. A NON-CONFORMANCE SEARCH WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED FOR THE PART/LOT NUMBER COMBINATION.

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGERY, IT WAS OBSERVED THAT THE STERILE PACKAGING WAS DAMAGED WHEN THE CUSTOMER OPENED THE OUTSIDE PACKAGING. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30219 RGDLOOP ADJUSTABLE STND SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE MBI MEDOS INTERNATIONAL SàRL L689890 10886705024094

    Patients

    Seq Age Sex Outcome Treatment
    1