BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILAGRO ADV TAP, 7-8MM

    MDR report key: 12500400 · Received September 20, 2021

    Report

    Report Number
    1221934-2021-02744
    Event Type
    Malfunction
    Date Received
    September 20, 2021
    Date of Event
    September 7, 2021
    Report Date
    September 7, 2021
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    LXH
    UDI-DI
    10886705023158
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: BACKGROUND: IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN UNKNOWN PROCEDURE THE TAP OF THREE OF THE TAP 7MM-8MM - MILAGRO ADVANCE WERE DULL. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY WAS REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION. INVESTIGATION SUMMARY: THE MILAGRO ADV TAP, 7-8MM (PART #: 219496, LOT #: 2103001) WAS RECEIVED AND EVALUATED AT US CQ. UPON VISUAL INSPECTION, THERE WERE NO VISUAL DEFECTS OBSERVED WITH THE DEVICE. THE DEVICE SHOWS MINIMAL WEAR WITHOUT ANY PHYSICAL DAMAGE CONSISTENT WITH THE USAGE OF THE DEVICE, WHICH HAS NO IMPACT ON THE DEVICE FUNCTIONALITY. HENCE, THE REPORTED CONDITION CANNOT BE CONFIRMED. NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED BASED ON THE PROVIDED INFORMATION. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT TO WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. DEVICE HISTORY LOT: PRODUCT CODE: 219496. LOT NUMBER: 2103001. MFG. DATE: 15-APR-2021. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER (2103001), AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN UNKNOWN PROCEDURE THE TAP OF THREE OF THE TAP 7MM-8MM - MILAGRO ADVANCE WERE DULL. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE ARE AVAILABLE TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1396636 MILAGRO ADV TAP, 7-8MM BONE TAP, REUSABLE LXH DEPUY MITEK LLC US 219496 2103001 10886705023158

    Patients

    Seq Age Sex Outcome Treatment
    1