BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICK, HEAVY SHAFT

    MDR report key: 3857160 · Received June 9, 2014

    Report

    Report Number
    9680837-2014-00048
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 15, 2014
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    JYT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - BREAK; MATERIAL FRAGMENTATION. IN RESPONSE TO MEDTRONIC¿S REQUEST FOR DEVICE RETURN, THE DEVICE WAS RECEIVED BY MEDTRONIC¿S US MANUFACTURING SITE FOR EVALUATION (DETAILED AS FOLLOWS): ONE DEVICE WAS RECEIVED, PRODUCT NUMBER 3722067 FROM LOT 130701. ANALYSIS FOUND NO EVIDENCE OF BIOLOGICAL CONTAMINANTS AND NO SIGNS OF USE ... HOWEVER, A PORTION OF THE TIP MEASURING APPROXIMATELY 1.5MM IN LENGTH WAS BROKE OFF AND WAS NOT IN THE PACKAGE OR IN THE TIP PROTECTOR. THE BREAK POINT SHOWED DEFORMATION CONSISTENT WITH THE RIGHT ANGLED TIP BENT IN A DISTAL DIRECTION BEFORE THE BREAKAGE. THERE WAS NO EVIDENCE OF IMPROPER MANUFACTURING AND THERE WAS NO SIGNIFICANT DAMAGE TO THE PACKAGING TO INDICATE SHIPPING DAMAGE... THEREFORE MANUFACTURING HAS BEEN RULED AS A POTENTIAL CAUSE, HOWEVER BASED OFF OF THE SIZE OF THE TIP DAMAGE THIS DOES NOT NECESSARILY RULE OUT SHIPPING AND HANDLING. THE INFORMATION MOST LIKELY INDICATES THE TIP WAS BENT AND BROKE DURING THE REMOVAL OF THE TIP PROTECTOR WHICH IS EVIDENT BY THE SCRAPE PROCEEDING TOWARD THE END ON THE INSIDE DIAMETER WHERE THE TIP WOULD HAVE BEEN, WHICH IS NOT LIKELY TO HAVE OCCURRED UNLESS THE TIP WAS STILL ATTACHED AND FACING OUTWARD AS SHOWN ON THE PRODUCT ASSEMBLY DRAWING. BASED ON THE OBSERVATIONS; THE MOST LIKELY UNDERLYING CAUSE IS CONSISTENT WITH, MISHANDLING. RESULT: STRESS PROBLEM; FRACTURE PROBLEM. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Description of Event or Problem · 1

    UPON RECEIVING A 1.5MM PT 90 DEGREE PICK, IT WAS REPORTED THE ¿TIP WAS BENT¿ WHEN THE PACKAGE WAS OPENED. HOWEVER, ANALYSIS CONFIRMED THE TIP WAS BROKEN AND NOT BENT. THERE WAS NO PATIENT IMPACT OR INJURY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333938 PICK, HEAVY SHAFT PICK, MICROSURGICAL EAR JYT XOMED MICROFRANCE MFG 3722067 130701

    Patients

    Seq Age Sex Outcome Treatment
    1