BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNISPAN MENISCAL REPAIR 27DEG

    MDR report key: 7149034 · Received December 27, 2017

    Report

    Report Number
    1221934-2017-50117
    Event Type
    Malfunction
    Date Received
    December 27, 2017
    Date of Event
    November 29, 2017
    Report Date
    November 30, 2017
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. UDI: (B)(4). THE EXPIRATION DATE IS CURRENTLY UNAVAILABLE. SEE ASSOCIATED MEDWATCH: 1221934-2017-50108, 1221934-2017-50109, 1221934-2017-50110, 1221934-2017-50111, 1221934-2017-50112, 1221934-2017-50114, 1221934-2017-50115, 1221934-2017-50119, 1221934-2017-50120, 1221934-2017-50121, 1221934-2017-50122, 1221934-2017-50124, 1221934-2017-50126.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. UDI: (B)(4). THE EXPIRATION DATE IS CURRENTLY UNAVAILABLE. SEE ASSOCIATED MEDWATCH: 1221934-2017-50108, 1221934-2017-50109, 1221934-2017-50110, 1221934-2017-50111, 1221934-2017-50112, 1221934-2017-50113, 1221934-2017-50114, 1221934-2017-50115, 1221934-2017-50119, 1221934-2017-50120, 1221934-2017-50121, 1221934-2017-50122, 1221934-2017-50124.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4)  INCOMPLETE. THE EXPIRATION DATE IS NOT CURRENTLY AVAILABLE. ASSOCIATED MEDWATCH REPORT NUMBER: 1221934-2017-50108, 1221934-2017-50109, 1221934-2017-50110, 1221934-2017-50111, 1221934-2017-50112, 1221934-2017-50113, 1221934-2017-50114, 1221934-2017-50115, 1221934-2017-50117, 1221934-2017-50119, 1221934-2017-50120, 1221934-2017-50121, 1221934-2017-50122, 1221934-2017-50124, 1221934-2017-50126, 1221934-2018-55025

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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 DEVICES WERE RECEIVED AND EVALUATED VISUALLY BY NPD ENGINEER. THE SEVEN NEEDLES CANNOT BE DISTINGUISHED AS THE BATCH/ LOT NUMBER IS NOT PRINTED ON THE DEVICE. VISUAL OBSERVATIONS REVEALED 6 OF THEM MISSING BOTH IMPLANTS AND SUTURES. THE SEVENTH NEEDLE HAD BOTH IMPLANTS ARE ON NEEDLE SLOT NEAR THE DISTAL TIP OF THE NEEDLE, HENCE THE IMPLANTS WERE NEVER DEPLOYED. NO STRUCTURAL ANOMALIES WERE OBSERVED ON THE NEEDLE OR THE IMPLANTS. THIS FAILURE MODE RESULTS WHEN LOADING ROD (RED TRIGGER) IS BEING PRESSED ACCIDENTALLY BEFORE PRESSING THE DEPLOYMENT ROD (GREY TRIGGER). ANOTHER POSSIBLE ROOT CAUSE COULD BE THE DEPLOYMENT ROD (GREY TRIGGER) IS BENT UPWARDS, IT CAN DEPLOY BOTH IMPLANTS AT THE SAME TIME. SINCE THE GUN IS DISCARDED, WE CANNOT DISCERN ANY DEFINITE ROOT CAUSE AT THIS POINT OF TIME. NONCONFORMANCE REVIEW WAS PERFORMED AND TWO NCS WERE IDENTIFIED FOR LOT (3861586) NUMBER. THE COMPLAINT CONDITION IS UNRELATED TO THE NONCONFORMANCES. MOREOVER, NO NONCONFORMANCES WERE IDENTIFIED FOR THE OTHER 6 REPORTED 27 DEGREE NEEDLES. 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 AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. UDI: (B)(4)  INCOMPLETE. THE EXPIRATION DATE IS NOT CURRENTLY AVAILABLE. ASSOCIATED MEDWATCH REPORT NUMBER: 1221934-2017-50108, 1221934-2017-50109, 1221934-2017-50110, 1221934-2017-50111, 1221934-2017-50112, 1221934-2017-50113, 1221934-2017-50114, 1221934-2017-50115, 1221934-2017-50117, 1221934-2017-50119, 1221934-2017-50120, 1221934-2017-50121, 1221934-2017-50122, 1221934-2017-50124, 1221934-2017-50126, 1221934-2018-55025.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON OPENED 15 IMPLANTS AND 13 WERE DEFECTIVE. INDEED, EVERY TIME SURGEON WANTED TO DELIVER THE DEVICE, BOTH IMPLANT (2) INSTEAD OF 1 WERE DELIVERED. SURGEON DID NOT TRY TO CHANGE THE GUN BEFORE OPENING EVERY DEVICE. THIS IS REPORT 9 OF 14 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON OPENED 15 IMPLANTS AND 13 WERE DEFECTIVE. INDEED, EVERY TIME SURGEON WANTED TO DELIVER THE DEVICE, BOTH IMPLANT (2) INSTEAD OF 1 WERE DELIVERED. SURGEON DID NOT TRY TO CHANGE THE GUN BEFORE OPENING EVERY DEVICE. THIS IS REPORT 9 OF 14 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM AFFILIATE ON 13 FEBRUARY 2018: IT WAS REPORTED THAT THERE WAS A DELAY IN THE PROCEDURE, BUT IT IS UNKNOWN HOW LONG THE DELAY WAS. THE PROCEDURE WAS COMPLETED USING OTHER ANCHORS THAT WERE READILY AVAILABLE. IT IS UNKNOWN IF THERE WERE ANY PROCEDURAL OR PATIENT ANATOMY FACTORS WHICH MAY HAVE CONTRIBUTED TO THE BREAKAGE. THE ISSUE OCCURRED DURING AN INITIAL PROCEDURE. NO PORTION OF THE IMPLANT REMAINED IN THE PATIENT; NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION RECEIVED FROM AFFILIATE ON 19 OCTOBER 2018: A SEVENTH 12 DEGREE NEEDLE WAS RETURNED DUE TO HAVING AN ISSUE RELATED TO THE REPORTED COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927576 OMNISPAN MENISCAL REPAIR 27DEG SOFT-TISSUE MENISCAL REPAIR ANCHOR, BIOABSORBABLE MAI DEPUY MITEK 3861586

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening