BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN OMNISPAN NEEDLE

    MDR report key: 6812483 · Received August 22, 2017

    Report

    Report Number
    1221934-2017-10446
    Event Type
    Malfunction
    Date Received
    August 22, 2017
    Date of Event
    June 19, 2017
    Report Date
    August 22, 2017
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICES WERE NOT RETURNED BUT SIX UNUSED DEVICES UNDER THE SAME LOT NUMBER WERE RECEIVED AND EVALUATED. VISUAL OBSERVATION OF ALL SIX NEEDLES REVEALED NO ANOMALIES. ALL SIX NEEDLES WERE RETURNED IN THEIR ORIGINAL PACKAGING WITH THE SEAL UNBROKEN. TO TEST FUNCTIONALITY OF THE NEEDLES, ALL SIX WERE MATED WITH A TEST APPLIER AND FIRED ON A SAMPLE MATERIAL SIMULATING THE MENISCUS. ALL SIX FIRED BOTH OF THEIR IMPLANTS SUCCESSFULLY AND NO ANOMALIES WERE NOTED. THE REPORTED DESCRIPTION DID NOT SPECIFY WHICH NEEDLE FAILED IN WHICH WAY BUT NEVERTHELESS, ALL REPORTED CONDITIONS COULD NOT BE CONFIRMED. GIVEN THE CURRENT INFORMATION INITIALLY AND FROM FOLLOW-UPS, A ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED. A DHR HAS BEEN CONDUCTED FOR ALL SIX OF THE UNUSED LOTS (228140 ¿ 3912293, 228141 - L374535, 228141 - L196360, 228142 ¿ 3833426, 228142 ¿ 3873179, 228142 ¿ 3912145) AND THE RESULTS INDICATE THAT ALL SIX BATCHES OF PRODUCTS WERE PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED ONE SIMILAR COMPLAINT FOR ONE (228141 - L196360, DOUBLE DEPLOYMENT) OF THESE SIX LOTS OF DEVICES THAT WAS RELEASED TO DISTRIBUTION. AT THIS POINT, 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS ONE MEDWATCH IS BEING FILED TO REFLECT THE ONE CASE OF DOUBLE DEPLOYMENT THAT WAS MENTIONED IN THE REPORTED DESCRIPTION. THE OTHER "MULTIPLE" PROCEDURES WERE FOUND TO BE NOT REPORTABLE BUT THERE WAS NO DISTINCTION PROVIDED IN WHICH PRODUCTS/LOTS WERE ASSOCIATED WITH THE DOUBLE DEPLOYMENT. THUS, THE PRODUCT BEING REPORTED IS AN UNKNOWN DEVICE WITH AN UNKNOWN LOT NUMBER.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED VIA EMAIL PRIOR TO BEING USED FOR A KNEE ARTHROSCOPY, THE NEEDLES ALL ARE SUPPOSED TO WORK WITH THE APPLICATOR BUT SOME OF THEM COULD NOT BE UNLEASHED WITH THE APPLICATOR OR THEY PERMEATED THROUGH THE SILICONE JACKET. THE PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON 6-26-2017: IN ONE CASE IT WAS BEFORE USE ON THE PATIENT, IN ANOTHER CASE IT WAS WHILE THE PROCEDURE (BOTH OF THE IMPLANTS SLIPPED OUTSIDE THE NEEDLE WHEN THE DOCTOR WANTED TO IMPLANT JUST THE FIRST IMPLANT. THE EVENT DID OCCUR DURING A PROCEDURE. THE PROCEDURE TYPE WAS A KNEE ARTHROSCOPY. NO, THERE WERE MANY PROCEDURES ON THIS DATE. IN EVERY CASE THE DOCTORS HAD PROBLEMS WITH THE NEEDLES. MULTIPLE GUNS WERE USED WITH THESE NEEDLES THE FAILURE WAS THE NEEDLES WOULD NOT DEPLOY. THE PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT. I DO NOT KNOW WHICH PRODUCT CODE THE DOCTOR USED TO COMPLETE THE PROCEDURE THEY ARE 228141-L196360, 228142 ¿ 387317, AND 228142-3912145. NO, ALL OF THEM WILL COME BACK. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON 6-30-2017: THE SALES REP STATES, THAT THEY MADE THE DECISION TO REMOVE ALL THE NEEDLES FROM THE CUSTOMER WITH OUR MARKETING DEPARTMENT. FOR THAT REASON SHE IS UNABLE TO STATE WHICH HAS BEEN USED AND FOR WHAT. SOME NEEDLES HAVE NOT BEEN USED AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591065 UNKNOWN OMNISPAN NEEDLE SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1