BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK PANALOK LOOP ANCHOR

    MDR report key: 2863818 · Received December 10, 2012

    Report

    Report Number
    1221934-2012-00338
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    August 22, 2012
    Report Date
    December 7, 2012
    Manufacturer
    DEPUY MITEK
    Product Code
    GAM
    PMA / PMN Number
    K040827
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOTHING IS BEING RETURNED FOR EVALUATION, THE INSERTER WAS DISCARDED AT THE USER FACILITY. THE COMPLAINT DEVICE WAS BEING USED OFF LABEL IN A HIP PROCEDURE. THE COMPLAINT DEVICE WAS ALSO BEING USED AT AN IMPROPER ANGLE AS ADMITTED BY THE SURGEON, A TECHNIQUE RELATED ISSUE. AT THIS POINT IN TIME, NO CORRECTIVE OR FURTHER ACTION IS WARRANTED, HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FUTURE INFORMATION RECEIVED THAT IS RELATIVE AND GERMANE TO THIS ISSUE. ALSO, 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 EVALUATED BY MFR: DISCARDED BY CUSTOMER.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE IS UNAVAILABLE FOR A PHYSICAL EVALUATION. THE COMPLAINT DEVICE WAS REPORTED TO BE FROM ONE OF THREE POSSIBLE LOT NUMBERS. WITHOUT CERTAINTY OF WHICH LOT THE COMPLAINT DEVICE WAS FROM, A BATCH RECORD REVIEW HAS BEEN CONDUCTED ON THE THREE REPORTED LOTS OF PRODUCT TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT ALL THREE BATCHES OF PRODUCT WERE PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY KIND FOR ALL THREE LOTS OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. THE COMPLAINT WAS FORWARDED TO THE MITEK ENGINEERING TEAM FOR THEIR REVIEW. WHILE A ROOT CAUSE COULD NOT BE DETERMINED, IT WAS NOTED THAT THE DEVICE IS NOT INDICATED FOR HIP PROCEDURES PER THE IFU. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY 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.

    Description of Event or Problem · 1

    OUR AFFILIATE REPORTED THAT THE INSERTER TIP BROKE OFF OF A PANALOK LOOP ANCHOR DURING A HIP LABRAL TEAR REPAIR PROCEDURE. THE SURGEON LEFT THE TIP OF THE INSERTER IN THE PATIENT'S BONE DUE TO HOW DIFFICULT IT WOULD BE TO REMOVE IT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NOTATION OF NO ADVERSE PATIENT SYMPTOMS. THE COMPLAINT DEVICE WAS BEING USED OFF LABEL BY THE SURGEON, WITH COMMENT FROM THE SURGEON THAT THE ANGLE OF THE INSERTER DURING ANCHOR INSERTION WAS NOT APPROPRIATE. THE COMPLAINT DEVICE WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK PANALOK LOOP ANCHOR SOFT TISSUE FIXATION DEVICE GAM DEPUY MITEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR