BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI QA+ #2/O OCORD V-5

    MDR report key: 7874542 · Received September 13, 2018

    Report

    Report Number
    1221934-2018-54637
    Event Type
    Malfunction
    Date Received
    September 13, 2018
    Report Date
    August 14, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    JDR
    UDI-DI
    10886705001835
    PMA / PMN Number
    K071257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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

    (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. UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT THE ALLEGED MALFUNCTION COULD NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. H11: CORRECTED DATA: B1, H1: THE ORIGINAL COMPLAINT WAS REVIEWED AND DETERMINED TO BE NOT REPORTABLE DUE TO OUR REPORTABILITY MATRIX.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4)-INCOMPLETE. THE LOT NUMBER IS NOT CURRENTLY AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT VIA EMAIL THAT THE PATIENT WHO HAD AN INJURY OF THE MIDDLE FINGER PIP JOINT WITH SURGERY OF INSERTION OF A MITEK ANCHOR MODEL PRODUCT CODE 212035: DEPUY MITEK MINI QUICKANCHOR PLUS (2/0 SUTURE). THE PATIENT STATED THAT DURING THE NEARLY 1 YEAR RECOVERY, BECAUSE OF THE SURGERY DOCTOR QUALITY. THE MITEK ANCHOR IS MAKING THE PATIENT HAVE AN UNCOMFORTABLE FEELING WITH A BIT OF SWELLING OF THE JOINT. AFTER HIS CONSULTANCY WITH THE GOOD DOCTOR IN WHICH IS HEALING HIM IN A BETTER WAY. THE PATIENT STATED THAT HE WOULD LIKE TO EXPLORE ANY POSSIBILITIES FOR THE REMOVAL OF THE INSERTED MITEK ANCHOR AS HIS FINGER TISSUE IS RECOVERED ALREADY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713730 MINI QA+ #2/O OCORD V-5 SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE JDR DEPUY MITEK LLC US 10886705001835

    Patients

    Seq Age Sex Outcome Treatment
    1 Other