BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIGIDFIX CROSS PIN KIT

    MDR report key: 2181667 · Received July 27, 2011

    Report

    Report Number
    1221934-2011-00281
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    March 31, 2011
    Report Date
    May 25, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    PMA / PMN Number
    K974341
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOTHING IS BEING RETURNED FOR EVALUATION; THE COMPLAINT DEVICE WAS DISCARDED AT THE USER FACILITY. A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO OTHER SIMILAR COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. IN COMPLAINT NARRATIVE IT STATES THAT THE SURGEON USED THE PROPER PROTOCOLS AND EQUIPMENT AND GOES ON TO DESCRIBES THE SURGEON HAVING TROUBLE DRILLING THE BONE HOLE; SLOW GOING, AND HAVING DIFFICULTY FREEING THE GUIDE SLEEVES FROM THE BONE. IT IS POSSIBLE THAT THE BONE QUALITY AT THIS DRILL SITE WAS VERY DENSE AND HARD, WHICH MAY HAVE BEEN THE CONTRIBUTOR TO THE DEVICE FAILURE: OUTSIDE OF THAT CONSIDERATION, WE CANNOT DISCERN ANY OTHER ROOT CAUSE FOR THE REPORTED EVENT. AT THIS POINT IN TIME NO FURTHER ACTION IS WARRANTED, HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FUTURE INFORMATION RECEIVED THAT IS RELATIVE, GERMANE AND CLARIFYING 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.

    Additional Manufacturer Narrative · 1

    AT THIS POINT IN TIME NO FURTHER ACTION IS WARRANTED, HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FUTURE INFORMATION RECEIVED THAT IS RELATIVE, GERMANE AND CLARIFYING 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 TO US THAT DURING AN ARTHROSCOPIC KNEE REPAIR THE SURGEON HAD DIFFICULTIES DRILLING THE 2ND "TROCAR/GUIDE SLEEVE" INTO THE BONE; WAS LOW GOING. AT THE POINT OF REMOVAL, THE SURGEON WAS USING THE SLEEVE REMOVAL TOOL TO REMOVE THE SLEEVE; HOWEVER, THE SLEEVE WOULD NOT COME OUT OF THE BONE. THE SURGEON STEADIED THE SLEEVE WITH PLIERS AND ATTEMPTED TO MALLET IT FURTHER INTO THE BONE IN AN ATTEMPT AT LOOSENING THE SLEEVE, HOWEVER THAT APPROACH FAILED. THE SURGEON MADE OTHER PHYSICAL ATTEMPTS AT RETRIEVING THE SLEEVE, BUT TO NO AVAIL. EVENTUALLY THE SLEEVE BROKE AT THE BONE; THE SURGEON USED A CORING BIT TO REMOVE THE SLEEVE AND FILLED THE VOID WITH BONE MATERIAL FROM THE "AUTOGRAFT" TAKEN TO REPAIR THE ACL: THE PROCEDURE WAS EXTENDED BY 1 HOUR AND 15 MINUTES. THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. NOTHING IS BEING RETURNED, THE COMPLAINT DEVICE WAS DISCARDED AT THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIGIDFIX CROSS PIN KIT SOFT TISSUE FIXATION DEVICE MAI DEPUY MITEK NA 3415245

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention