BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGIDFIX FEMROD 9MM *EA

    MDR report key: 7596058 · Received June 13, 2018

    Report

    Report Number
    1221934-2018-51698
    Event Type
    Malfunction
    Date Received
    June 13, 2018
    Date of Event
    October 1, 2017
    Report Date
    May 31, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    FZX
    UDI-DI
    10886705003037
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUALLY, THE DEVICE SEEMED TO BE IN GOOD CONDITION. AS REPORTED THE DEVICE WAS NOT USED, NO PROCEDURE WAS INVOLVED. UPON FURTHER OBSERVATION THE CORRECT ETCHING WAS SHOWN ON THE DEVICE. THIS COMPLAINT IS NOT CONFIRMED. PART NUMBER:213709 HAS ETCHING OF ¿SOFT TISSUE ONLY¿, WHICH WAS CONFIRMED ON THE DRAWING, HOWEVER, THIS WILL BE FURTHER REVIEWED UNDER MITEK PIA. THE DHR REVIEW INDICATED THAT THIS BATCH OF DEVICES WAS PROCESSED WITHOUT INCIDENT THEREFORE, THERE IS NO EVIDENCE OF MANUFACTURING ANOMALIES ON THE RECORDS REVIEWED. FURTHERMORE, A RELATED COMPLAINT SEARCH IN DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO COMPLAINTS OF ANY TYPE FOR THIS LOT OF DEVICES THAT WAS RELEASED TO DISTRIBUTION. 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. UDI: (B)(4). ASSOCIATED MEDWATCH: MR#1221934-2018-51697, MR#1221934-2018-51699, AND MR#1221934-2018-51700.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4). ASSOCIATED MEDWATCH: [MR#1221934-2018-51697], [MR#1221934-2018-51699], [MR#1221934-2018-51700].

    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. UDI: (B)(4). ASSOCIATED MEDWATCH: [MR#1221934-2018-51697], [MR#1221934-2018-51699], [MR#1221934-2018-51700].

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT "SOFT TISSUE ONLY" WAS ETCHED INTO TWO OF HIS RIGIDFIX FEMORAL ROD 10MM AND TWO OF HIS RIGIDFIX FEMORAL ROD 9MM WHEN THEY ARE IN FACT BTB DEVICES. THERE WAS NO CASE OR PATIENT INVOLVEMENT. THE DEVICES ARE BEING RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438390 RIGIDFIX FEMROD 9MM *EA BONENAIL GUIDEWIRE FZX DEPUY MITEK LLC US 1702555 10886705003037

    Patients

    Seq Age Sex Outcome Treatment
    1