BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOINTRAFIX SHEATH INSERTER

    MDR report key: 2051317 · Received April 6, 2011

    Report

    Report Number
    1221934-2011-00146
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTHING IS BEING RETURNED FOR EVAL; COMPLAINT DEVICE DISCARDED AT USER FACILITY. NO LOT NUMBER HAS BEEN SUPPLIED, WHICH PRECLUDES CONDUCTING A BATCH RECORD REVIEW TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. WE CANNOT TELL ANYTHING FROM THIS; CANNOT DISCERN THE UNDERLYING OR ROOT CAUSE FOR THE REPORTED DEVICE'S FAILURE MODE. BECAUSE OF THE EXTENDED SURGERY TIME, THE MORE INVASIVE INCISION, AND THE ADD'L PROPHYLACTIC DOSE OF ANTIBIOTICS FOR REMEDY IS THIS REPORT BEING FILED TO DOCUMENT THE EVENT. AT THIS POINT IN TIME, NO CORRECTIVE OR FURTHER ACTION IS WARRANTED; HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FUTURE INFO RECEIVED THAT IS RELATIVE AND GERMANE 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.

    Description of Event or Problem · 1

    OUR REP IS REPORTING THAT DURING A KNEE PROCEDURE, A PORTION OF THE DISTAL TIP OF A BIOINTRAFIX SHEATH INSERTER FELL OFF INTO THE FIXATION DEVICE. A LARGER INCISION WAS NEEDED TO REMOVE THE TIP. THIS ADDED AN HOUR TO THE PROCEDURE. THE PT'S ANTIBIOTICS WERE INCREASED TO COMPENSATE FOR THE EXTENDED TIME IN SURGERY. THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOINTRAFIX SHEATH INSERTER ARTHROSCOPIC INSTRUMENT HRX DEPUY MITEK 254618 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention