BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-INTRAFIX TIBIAL SHEATH - LARGE

    MDR report key: 6367069 · Received February 28, 2017

    Report

    Report Number
    1221934-2017-10075
    Event Type
    Injury
    Date Received
    February 28, 2017
    Date of Event
    November 30, 2016
    Report Date
    February 2, 2017
    Manufacturer
    DEPUY MITEK
    Product Code
    HWC
    PMA / PMN Number
    K032167
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT AVAILABLE FOR A PHYSICAL EVALUATION. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. A DHR REVIEW HAS BEEN CONDUCTED AND THE RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT ANY INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, SHOULD ANY NEW INFORMATION BE PROVIDED IN FUTURE, THIS FILE WILL BE RE-OPENED AND A THOROUGH INVESTIGATION WILL BE PERFORMED. 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. UDI: (B)(4). ASSOCIATED MEDWATCH: 1221934-2017-10076.

    Description of Event or Problem · 1

    THE SALES REP REPORTED ONE PATIENT HAD AN INFECTION POST ACL PROCEDURE. THE FIRST AND SECOND FOLLOW UP VISITS WERE FINE, BUT THE THIRD FOLLOW UP THE PATIENT PRESENTED WITH KNEE PAIN AND SWELLING AROUND THE INCISION. THE SALES REP IS CONTACTING THE DOCTOR FOR PROCEDURE DATES AND ADDITIONAL DETAILS. THE PATIENT IS OK NOW. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE SALES REP ON 2-6-2017 ACCORDING TO THE PHYSICIAN'S CARE TEAM MEMBER, IMPLANTS WERE REMOVED FROM 2 OF THE 4 PATIENTS. (B)(6) 20/16- PSC. ACL RECON WITH HAMSTRING AUTOGRAFT. SHEATH: REF: 254628, LOT: 3914533. SCREW : R: 254624, LOT: 3922444. REMOVED: (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149507 BIO-INTRAFIX TIBIAL SHEATH - LARGE MITEK ACL IMPLANTS HWC DEPUY MITEK 3914533

    Patients

    Seq Age Sex Outcome Treatment
    1 Other