BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO QA+ #3/0 OC V4

    MDR report key: 9444579 · Received December 10, 2019

    Report

    Report Number
    1221934-2019-59916
    Event Type
    Injury
    Date Received
    December 10, 2019
    Date of Event
    November 19, 2019
    Report Date
    November 20, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    UDI-DI
    10886705002375
    PMA / PMN Number
    K080352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. 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. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS DISCARDED BY THE CUSTOMER, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. WITH THE INFORMATION PROVIDED, AND WITHOUT THE COMPLAINT DEVICE TO EVALUATE, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER: (1L85568), 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. DEVICE HISTORY LOT: AN MRE REVIEW WAS PERFORMED AND RESULTS REVEALED THAT THERE WERE NO ANOMALIES OR DISCREPANCIES ON LOT NUMBER: 1L85568.

    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. 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 NARRATIVE: ADDITIONAL INFORMATION: LOT AND EXP DATE: THE LOT NUMBER AND EXP DATE WERE REPORTED AS UNKNOWN IN THE INITIAL REPORT. BOTH FIELDS HAVE BEEN REPORTED AND UPDATED ACCORDINGLY. THEREFORE, UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    (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. (B)(4). THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA CST THAT DURING A FLEXOR TENDON REPAIR PROCEDURE, THE SURGEON PLACED THE MICRO QA+ #3/0 OC V4 IN THE DESIRED POSITION AND BEGAN TO PASS THE SUTURE THROUGH THE TENDON TO TIE IT DOWN. HOWEVER, THE SUTURE SNAPPED AT THE EYELET OF THE ANCHOR AND BECAME UNUSABLE. THE SURGEON WAS FORCED TO REMOVE THE SUTURE AND ALSO DIG THE ANCHOR OUT OF THE BONE. NO FRAGMENTS WERE LEFT BEHIND. THE ANCHOR WAS COMPLETELY REMOVED AND A NEW ANCHOR (MINI QA) WAS PLACED IN THE SAME SPOT AS THE PREVIOUS ANCHOR (AFTER DRILLING OVER THE OLD HOLE WITH THE NEW DRILL BIT). THE PATIENT HAD GOOD, DENSE BONE. 3 MINUTES DELAY WAS REPORTED. NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239659 MICRO QA+ #3/0 OC V4 SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE HWC DEPUY MITEK LLC US 1L85568 10886705002375

    Patients

    Seq Age Sex Outcome Treatment
    1