BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILAGRO ADVANCE SCREW 8X30MM

    MDR report key: 8723260 · Received June 21, 2019

    Report

    Report Number
    1221934-2019-57394
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Date of Event
    May 16, 2019
    Report Date
    May 27, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    UDI-DI
    10886705022267
    PMA / PMN Number
    K123362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    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. H10 ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. UPON VISUAL INSPECTION THE PART APPEAR TO BE SHEARED AND INCOMPLETE. THE COMPLAINT IS CONFIRMED. A POSSIBLE ROOT CAUSE FOR THE SCREW TO BE SHEARED COULD POSSIBLY BE ATTRIBUTED TO EXCESSIVE FORCE APPLIED WHILE INSERTING THE SCREW. GIVEN THE INFORMATION PROVIDED IN THE DESCRIPTION OF THE EVENT, A DEFINITE ROOT CAUSE COULD NOT BE ESTABLISHED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 231821 LOT 2L06390, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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).

    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. H10 ADDITIONAL NARRATIVE: 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 · 0

    ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE EVENT OCCURRED DURING AN ACL RECONSTRUCTION AND NO PATIENT CONSEQUENCES WERE OBSERVED, THE AFFILIATE STATED THE PROCEDURE WAS COMPLETED WITH ANOTHER READILY AVAILABLE MILAGRO SCREW. IT WAS ALSO REPORTED THE INITIAL SCREW BROKE INTO 2 PIECES BUT ONLY HALF WAS REMOVED. THE OTHER HALF STAYED IN THE PATIENT, FIXED TO THE CRUCIATE. THE AFFILIATE REPORTED THE DOCTOR WAS NOT OFF AXIS, THE PATIENT HAD GOOD BONE QUALITY, AND THE SAME BONE HOLE WAS UTILIZED TO COMPLETE THE PROCEDURE. IT WAS ALSO REPORTED SURGICAL INTERVENTION IS NOT PLANNED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). 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 EMAIL THAT THE 8X30 MILAGRO ADVANCE SCREW BROKE WHEN SCREWED INTO THE CHANNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515523 MILAGRO ADVANCE SCREW 8X30MM ORTHOPAEDIC BONE SCREW, BIOABSORBABLE HWC DEPUY MITEK LLC US 2L06390 10886705022267

    Patients

    Seq Age Sex Outcome Treatment
    1