BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLOTTED MAXCUTTER

    MDR report key: 3912826 · Received July 3, 2014

    Report

    Report Number
    0001825034-2014-05939
    Event Type
    Injury
    Date Received
    July 3, 2014
    Report Date
    October 16, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. DEVICE AVAILABILITY - THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS.

    Additional Manufacturer Narrative · 1

    DEVICE WAS FORWARDED TO SUPPLIER MANUFACTURER FOR EVALUATION. EVALUATION FOUND THE INSTRUMENT WAS NOT CLEANED PROPERLY RESULTING IN THE INSTRUMENT UNABLE TO FUNCTION. PICTURE OF HANDLE MECHANISM SHOWS LARGE QUANTITY OF MATERIAL CLOGGING THE MECHANISM. A REVIEW OF MANUFACTURING RECORDS REVEALED THE INSTRUMENT WAS MADE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A ROTATOR CUFF REPAIR UTILIZING A SLOTTED MAXCUTTER ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SURGEON WAS UNABLE TO CUT THE SUTURE WITH THE SLOTTED MAXCUTTER CAUSING A DELAY OVER AN HOUR. IT WAS FURTHER REPORTED THE PROCEDURE WAS COMPLETED USING ARTHROSCOPIC SCISSORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391203 SLOTTED MAXCUTTER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET ORTHOPEDICS N/A 089030

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R