BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRAFIX TAPERED SCREW 7-9MM X 30MM (ACETAL/DELRIN)

    MDR report key: 3935114 · Received July 15, 2014

    Report

    Report Number
    1221934-2014-00299
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    PMA / PMN Number
    K983560
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. FURTHERMORE, NO LOT NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A BATCH HISTORY REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. FROM THE INFORMATION PROVIDED, A ROOT CAUSE FOR THIS ISSUE CANNOT BE DETERMINED. THIS FAILURE WAS REVIEWED AGAINST THE RISK ANALYSIS AND FOUND TO BE WITHIN THE EXPECTED LEVELS. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, THIS FILE WILL REMAINS RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. DEPUY 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

    ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION ABOUT THE EVENT. THE ADDITIONAL INFORMATION WILL REPORTEDLY BE FORWARDED TO DEPUY MITEK; HOWEVER, IT IS NOT KNOWN IF IT WILL BE RECEIVED WITHIN THE 30 DAY REPORTING REQUIREMENT, THEREFORE, DEPUY MITEK WOULD LIKE TO FILE THIS INITIAL MEDWATCH REPORT AT THIS TIME. WHEN AND IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REFLECTED IN A FOLLOW-UP MEDWATCH REPORT.

    Description of Event or Problem · 1

    RIGHT KNEE REVISION. PRIMARY SURGERY (B)(6) 2013. NIL ORIGINAL BATCH DETAILS AVAILABLE AT THIS TIME. LIST OF IMPLANTS: 7-9 INTRAFIX TIBIAL TAPERED SCREW, 30MM INTRAFIX TIBIAL SHEATH, 7.5MM TIBIAL TUNNEL. TIE TENSIONER USED FOR PRIOR TO AND DURING IMPLANTING OF THE INTRAFIX. ROTATIONAL TAB AT 12 O'CLOCK POSITION IN CORTICAL BONE. HARD BONE. TIBIAL TUNNEL ANGLE OF 55 DEGREES. REVISED ON (B)(6) 2014, DUE TO THE SHEATH AND SCREW BEING PROUD ON THE ANTERIOR TIBIAL CORTEX. PROF (B)(6) IS CONCERNED AS HE HAS HAD A FEW PATIENT'S RETURNING WITH THIS PROBLEM. HE HAS BEEN USING THIS PRODUCT FOR MANY YEARS AND FEELS THERE NEEDS TO BE A SHORTER SCREW FOR SMALLER PATIENTS. HE IS GREATLY CONCERNED ABOUT THE SCREW PROTRUDING INTO THE TIBIAL/FEMORAL JOINT SPACE AND IS DILIGENT ABOUT HOW FAR THE SCREW IS SEATED AT TIME OF INSERTION. HE HAS OBSERVED THAT THIS IS MAINLY IN THE FEMALE PATIENT GROUP.

    Description of Event or Problem · 1

    RIGHT KNEE REVISION. PRIMARY SURGERY (B)(6) 2015. NIL ORIGINAL BATCH DETAILS AVAILABLE AT THIS TIME. LIST OF IMPLANTS: 7-9 INTRAFIX TIBIAL TAPERED SCREW, 30MM INTRAFIX TIBIAL SHEATH, 7.5MM TIBIAL TUNNEL. TIE TENSIONER USED FOR PRIOR TO AND DURING IMPLANTING OF THE INTRAFIX. ROTATIONAL TAB AT 12 O?CLOCK POSITION IN CORTICAL BONE. HARD BONE. TIBIAL TUNNEL ANGLE OF 55 DEGREES. REVISED ON (B)(6) 2014 DUE TO THE SHEATH AND SCREW BEING PROUD ON THE ANTERIOR TIBIAL CORTEX. PROF BRUCE IS CONCERNED AS HE HAS HAD A FEW PATIENT?S RETURNING WITH THIS PROBLEM. HE HAS BEEN USING THIS PRODUCT FOR MANY YEARS AND FEELS THERE NEEDS TO BE A SHORTER SCREW FOR SMALLER PATIENTS. HE IS GREATLY CONCERNED ABOUT THE SCREW PROTRUDING INTO THE TIBIAL/FEMORAL JOINT SPACE AND IS DILIGENT ABOUT HOW FAR THE SCREW IS SEATED AT TIME OF INSERTION. HE HAS OBSERVED THAT THIS IS MAINLY IN THE FEMALE PATIENT GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411970 INTRAFIX TAPERED SCREW 7-9MM X 30MM (ACETAL/DELRIN) SOFT-TISSUE ANCHOR, NON-BIODEGRADABLE MBI DEPUY MITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention