BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSEW FLEXIBLE SUTURE PASSER NEEDLE

    MDR report key: 1001872 · Received February 25, 2008

    Report

    Report Number
    1221934-2008-00079
    Event Type
    Malfunction
    Date Received
    February 25, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 14, 2008
    Manufacturer
    DEPUY MITEK,
    Product Code
    HRX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS NOT YET BEEN RECEIVED, HOWEVER, HISTORICALLY, THIS TYPE OF FAILURE HAS BEEN ATTRIBUTED TO THE POSSIBILITY THAT THE USER MAY HAVE HIT BONE OR SOME OTHER OBJECT 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 AND CONSIDERATION NO CONCLUSIONS CAN BE DRAWN. WHEN THE COMPLAINT DEVICE IS RECEIVED HERE AT DEPUY MITEK IT WILL BE SUBJECTED TO A ROOT CAUSE ANALYSIS. IF THE ANALYSIS IDENTIFIES ANY DEFINITIVE ROOT CAUSE A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    OUR REP REPORTS THAT DURING 2 SEPARATE ARTHROSCOPIC SHOULDER REPAIRS, A PORTION OF THEIR DISTAL TIP OF AN EXPRESSEW FLEXIBLE SUTURE PASSER NEEDLES BROKE OFF INTO THE PATIENT'S JOINT SPACE. THE FRAGMENTS WERE RETRIEVED FROM THE BODIES AND THE PROCEDURES WERE CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. SEE ALSO ASSOCIATED MDR 1221934-2008-00080.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESSEW FLEXIBLE SUTURE PASSER NEEDLE ARTHROSCOPIC INSTRUMENT HRX DEPUY MITEK, 214005 A708028

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK