BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSEW FLEXIBLE SUTURE PASSER NEEDLE

    MDR report key: 2180007 · Received July 27, 2011

    Report

    Report Number
    1221934-2011-00275
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    April 12, 2011
    Report Date
    July 25, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS BEEN RECEIVED AND EVALUATED VISUALLY, BOTH WITH THE NAKED EYE AND UNDER POWER: THERE IS A PORTION OF THE DISTAL TIP THAT MISSING; BROKEN OFF OF THE NEEDLE. A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS 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 THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT CONCLUDE AS TO WHAT MAY HAVE CAUSED THE NEEDLE TO BREAK. IT IS POSSIBLE THAT THE USER MAY HAVE HIT BONE WHEN DEPLOYING THE NEEDLE THROUGH THE SOFT TISSUE CAUSING THE DISTAL PORTION OF THE NEEDLE TO POSSIBLY FATIGUE AND BREAK OFF. ALSO, THIS IS A SINGLE USE DEVICE AND IT WAS NOT ESTABLISHED THAT THE DEVICE WAS USED ONLY ONCE, WHICH COULD HAVE LED TO THIS PARTICULAR FAILURE MODE AS WELL. OUTSIDE OF THESE HYPOTHESES, NO CONCLUSIONS CAN BE DRAWN. AT THIS POINT IN TIME NO FURTHER ACTION IS WARRANTED, HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FUTURE INFORMATION RECEIVED THAT IS RELATIVE, GERMANE AND CLARIFYING 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.

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE RISK MANAGER FROM THE USER FACILITY IS REPORTING THAT DURING AN ARTHROSCOPIC SHOULDER PROCEDURE, A PORTION OF THE DISTAL TIP OF AN EXPRESSEW SUTURE PASSER NEEDLE BROKE OFF INTO THE PATIENT'S JOINT SPACE. THE FRAGMENT WAS RETRIEVED FROM THE BODY AND THE REPAIR WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESSEW FLEXIBLE SUTURE PASSER NEEDLE ARTHROSCOPIC INSTRUMENTS LXH DEPUY MITEK NA A102027

    Patients

    Seq Age Sex Outcome Treatment
    1