BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIO-INTRAFIX

    MDR report key: 8836209 · Received July 29, 2019

    Report

    Report Number
    1221934-2019-57827
    Event Type
    Injury
    Date Received
    July 29, 2019
    Report Date
    July 5, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME, COMMON DEVICE NAME, PROCODE, MFR, LOT #, PART #, UDI #, 510K: THIS REPORT IS FOR AN UNKNOWN BIO-INTRAFIX. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). DEVICE EVALUATED BY MFR, MANUFACTURE DATE: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: BENT LUND IN ET AL, 2014, ¿IS QUADRICEPS TENDON A BETTER GRAFT CHOICE THAN PATELLAR TENDON? A PROSPECTIVE RANDOMIZED STUDY¿, THE JOURNAL OF ARTHROSCOPIC AND RELATED SURGERY, VOL 30, NO 5 (MAY), PAGE 593-598, DENMARK. THE STUDY EMPHASIZES ON COMPARING KNEE STABILITY, KNEELING PAIN, HARVEST SITE PAIN, SENSITIVITY LOSS, AND SUBJECTIVE CLINICAL OUTCOME AFTER PRIMARY ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION WITH EITHER BONE-PATELLAR TENDON-BONE (BPTB) OR QUADRICEPS TENDON-BONE (QTB) AUTOGRAFTS IN A NONINFERIORITY RANDOMIZED CONTROLLED STUDY DESIGN. THE PATIENTS EVALUATED ON COURSE OF STUDY: TOTAL (51 PATIENTS ) WHO UNDERWENT ACL RECONSTRUCTION WITH EITHER BPTB (22 MALES AND 4 FEMALE WITH AVERAGE AGE RANGE 31 YEARS) OR QTB (20 MALES AND 5 FEMALE WITH AVERAGE AGE RANGE 30 YEARS) AUTOGRAFTS WERE ENROLLED FROM 2005 TO 2009. THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTIONS WERE PERFORMED ARTHROSCOPICALLY USING BPTB OR QTB GRAFT HARVESTING TECHNIQUES. FOLLOW-UP WAS PERFORMED AT 1 AND 2 YEARS POSTOPERATIVELY. THE DEVICE INVOLVED ARE: A SCREW AND SHEET INTRAFIX ALONG WITH TITANIUM INTERFERENCE SCREW WAS USED TO FIX QTB GRAFT IN THE TIBIA. THE BPTB GRAFT WAS FIXED AT BOTH ENDS WITH TITANIUM INTERFERENCE SCREWS. THE TENDON END WAS SECURED WITH A BASEBALL SUTURE. NO MITEK DEVICE WAS USED IN BPTB GROUP. COMPLICATIONS MENTIONED IN THE ARTICLE WERE: SUPERFICIAL INFECTION WAS REPORTED IN ONE PATIENT AND ANOTHER ONE WAS PRESENTED WITH MEDIAL PAIN DUE TO INFLAMED MEDIAL PLICA 2 YEARS POSTOPERATIVELY IN THE QTB GROUP. DURING THE 2-YEAR FOLLOW-UP PERIOD, ONE PATIENT IN EACH GRAFT GROUP HAD REMOVAL OF A TIBIAL GRAFT FIXATION SCREW BECAUSE OF LOCALIZED PAIN AND SCREW PROTRUSION. ONE PATIENT FROM THE BPTB GROUP HAD GRAFT RUPTURE RESULTING FROM NEW AND HAD REVISION ACL RECONSTRUCTION WITH AN ALLOGRAFT. ONE PATIENT IN THE BPTB GROUP HAD A MENISCAL INJURY THAT WAS TREATED WITH PARTIAL MENISCECTOMY. FROM THE REVIEW OF THE ARTICLE IT IS CONCLUDED THAT MITEK DEVICE CANNOT BE DISASSOCIATED WITH REPORTED ADVERSE EVENTS LIKE MEDIAL PAIN DUE TO INFLAMED MEDIAL PLICA AND REMOVAL OF A TIBIAL GRAFT FIXATION SCREW BECAUSE OF LOCALIZED PAIN AND SCREW PROTRUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630295 UNKNOWN BIO-INTRAFIX SOFT-TISSUE ANCHOR, BIOABSORBABLE HWC DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention