BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0 CM LONG ATTACHMENT

    MDR report key: 7390011 · Received April 2, 2018

    Report

    Report Number
    1045834-2018-50660
    Event Type
    Malfunction
    Date Received
    April 2, 2018
    Date of Event
    January 1, 2017
    Report Date
    December 4, 2017
    Manufacturer
    DEPUY SYNTHES PRODUCTS LLC
    Product Code
    HBC
    UDI-DI
    845384003571
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE MANUFACTURE DATE: THE DEVICE MANUFACTURE DATE IS UNAVAILABLE. (B)(6). THE DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. THE DEVICE WAS EVALUATED AND THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO IMPROPER HANDLING, WHICH IS USER ERROR/MISUSE/ABUSE, NORMAL WEAR, AND BE IMPROPER CONSTRUCTION AND DESIGN. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IT WAS DOCUMENTED IN THE INITIAL REPORT THAT THE SERIAL NUMBER WAS (B)(4). THE DEVICE HAS BEEN RECEIVED AND IT WAS NOTED THAT THE SERIAL NUMBER OF THE DEVICE WAS UNREADABLE. THEREFORE, UDI: LOT/SERIAL UNKNOWN; (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IT WAS DOCUMENTED IN THE PREVIOUS MEDWATCH REPORT THAT THE SERIAL NUMBER WAS UNREADABLE. THE DEVICE HAS BEEN RECEIVED AND IT WAS NOTED THAT THE SERIAL NUMBER OF THE DEVICE WAS (B)(4). THE UNIQUE IDENTIFIER (UDI) AND DATE OF MANUFACTURE HAVE BEEN UPDATED ACCORDINGLY. UPON FURTHER INVESTIGATION OF THE DEVICE IT WAS NOTED THAT THE NOSE TIP WAS FLARED OUT, THE COLOR BANDS WERE TOO DULL, AND THE BEARINGS WERE FELL OUT IN THE DEVICE. THIS INFORMATION DOES NOT CHANGE THE ROOT CAUSE OF THE FAILURE. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    UPON FURTHER INVESTIGATION IT WAS DETERMINED THAT THE BEARING OF THE LONG ATTACHMENT DEVICE WAS FAILING WAS CONFIRMED. AN ASSESSMENT WAS PERFORMED AND IT WAS OBSERVED THAT A CUTTER COULD NOT BE INSERTED INTO THIS ATTACHMENT DEVICE, AND THE NOSE TUBE WAS DAMAGED (FLARED OUT ON THE END). IT WAS DETERMINED THAT THE CONDITION OF THE CANNOT INSERT CUTTER WAS DUE TO THE BEARINGS BEING WORN OUT AND NOT ALLOWING THE CUTTER TO PASS THROUGH AND SOME WERE MISSING. FAILURE WAS CAUSED BY WORN OUT BEARINGS FROM NORMAL WEAR AND SERVICING OVER TIME. THE CONDITION OF THE FLARED NOSE TUBE WAS DETERMINED TO BE DUE TO EXCESSIVE SIDE LOADING CAUSING THE CUTTER TO FLEX AND TO COME IN CONTACT WITH THE NOSE TUBE, AND NOT NORMAL WEAR AND SERVICING AND IS CAUSED FROM MISUSE, ABUSE AND OR ERROR. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BEARINGS OF THE LONG ATTACHMENT DEVICE WERE DAMAGED, IDENTIFICATION WAS UNREADABLE, THE NOSE CONE WAS DAMAGED, AND THERE WAS A COSMETIC DEFECT. IT WAS NOTED THAT THE BEARINGS HAD FALLEN APART, THE DEVICE WAS MISSING BALLS AND THE CAGE DID NOT EXIST, THE EXTENSION SLEEVE DAMAGED. HIKERS HP-0033-02 HIKED, THE COLOR MARKINGS WERE DAMAGED, AND THE LABEL WAS NO LONGER LEGIBLE. IT WAS NOTED IN THE SERVICE ORDER THAT THE BEARINGS HAD FAILED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2017. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232700 11.0 CM LONG ATTACHMENT MOTOR, DRILL, ELECTRIC - ATTACHMENT HBC DEPUY SYNTHES PRODUCTS LLC 845384003571

    Patients

    Seq Age Sex Outcome Treatment
    1