BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GII QA+ W #2 ORTHOCORD

    MDR report key: 6990719 · Received October 31, 2017

    Report

    Report Number
    1221934-2017-10646
    Event Type
    Malfunction
    Date Received
    October 31, 2017
    Report Date
    October 3, 2017
    Manufacturer
    DEPUY MITEK
    Product Code
    JDR
    PMA / PMN Number
    K051989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED; THEREFORE A PHYSICAL EVALUATION CANNOT BE CONDUCTED. THE REPORTED COMPLAINT CANNOT BE CONFIRMED AND A ROOT CAUSE THE REPORTED DEVICE FAILURE CANNOT BE DETERMINED. THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED WHICH PRECLUDES A DHR REVIEW AND A LOT SPECIFIC COMPLAINT HISTORY SEARCH. AT THIS 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 TO MONITOR THE EXTENT TO WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. (B)(4). DEPUY SYNTHES HAS BEEN INFORMED THAT THE LOT NUMBER IS NOT AVAILABLE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED VIA EMAIL THE DR NOTIFIED (B)(6) REP THAT "HE HAD, HAD AN ISSUE WITH SAID ANCHOR, WHERE THE SUTURE AND ANCHOR MEET, THE SUTURE HAD SNAPPED. SURGEON COULD NOT TELL (B)(6) REP WHEN, WHERE AND ON WHICH PATIENT THIS HAD HAPPENED ON". ACTION TAKEN: ANOTHER ANCHOR WAS USED. 5 MINUTE DELAY TO PROCEDURE. THE HOSPITAL HAVE REPORTED NO PRODUCT FAILURES. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON (B)(6) 2017: THE ISSUE WAS DETECTED DURING USE ON PATIENT. TYPE OF PROCEDURE IS UNKNOWN. IT IS UNKNOWN IF THE SURGEON USED THE ORIGINAL BONE HOLE TO COMPLETE THE PROCEDURE THE IMPLANTED ANCHOR WAS REMOVED AND DISCARDED. ALTERNATIVES WERE READILY AVAILABLE WAS ONLY A 5 MINUTE DELAY TO PROCEDURE. PATIENT OUTCOME AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770325 GII QA+ W #2 ORTHOCORD SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE JDR DEPUY MITEK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1