BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGIDFIX CROSS PIN

    MDR report key: 9150270 · Received October 3, 2019

    Report

    Report Number
    1221934-2019-58782
    Event Type
    Injury
    Date Received
    October 3, 2019
    Report Date
    October 1, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HTY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: F. HAMIDO, ET AL, 2015 ¿AUGMENTED SHORT UNDERSIZED HAMSTRING TENDON GRAFT WITH LARS ARTIFICIAL LIGAMENT VERSUS FOUR-STRAND HAMSTRING TENDON IN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION: PRELIMINARY RESULTS¿, ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH 101, PAGES 535-538 (KUWAIT). THE AIM OF THIS STUDY WAS TO COMPARE THE OUTCOME OF ACL RECONSTRUCTION USING AUGMENTED HAMSTRING TENDON GRAFT WITH LARS ARTIFICIAL LIGAMENT VERSUS A FOUR-STRAND HAMSTRING TENDON GRAFT (4- SHG) TO ASSESS THE EFFECTIVENESS OF THE TWO GRAFTS REGARDING TO KNEE STABILITY. FROM JUNE 2007 TO JULY 2008. 104 PATIENTS WITH ISOLATED TEAR OF ANTERIOR CRUCIATE LIGAMENT WERE RECONSTRUCTED USING EITHER (4-SHC) OR (LARS) AUGMENTED GRAFT. THE DIAGNOSIS OF CHRONIC LIGAMENT TEAR WAS IDENTIFIED BY POSITIVE LACHMAN. S-TEST. ANTERIOR DRAWER TEST PIVOT SHIFT TEST AND MAGNETIC RESONANCE IMAGING (MRI). EXCLUSION CRITERIA WERE PATIENTS LESS THAN 6 MONTHS FROM INJURY, COMBINED LIGAMENT INJURY, RADIOLOGICAL VISIBLE DEGENERATIVE CHANGES, CONTRALATERAL KNEE LIGAMENT INJURY AND FOLLOW-UP PERIOD LESS THAN FIVE YEARS. SEVENTY-TWO PATIENTS FULFILLED THESE CRITERIA AND WERE INCLUDED. TWENTY-SEVEN PATIENTS WERE FOUND HAVING INTRAOPERATIVELY EITHER SHORT HAMSTRING TENDONS (<15CM LENGTH) OR SMALL DIAMETER HARVESTED FOUR-STRAND GRAFT (LESS THAN 6 MM DIAMETER); THEY WERE RECONSTRUCTED WITH AUGMENTATION USING LARS® ARTIFICIAL LIGAMENT. FORTY-FIVE PATIENTS WERE RECONSTRUCTED WITH A (4-SHC). THE ARTICLE DESCRIBES THE FOLLOWING SURGICAL TECHNIQUE: ALL THE PATIENTS UNDERWENT ARTHROSCOPIC SINGLE BUNDLE ACL RECONSTRUCTION (RIGIDFIX TECHNIQUE MITEK JOHNSON & JOHNSON), THE TIBIAL TUNNEL WAS DRILLED USING THE AIMING GUIDES. FOR THE FEMORAL TUNNEL, AN APPROPRIATE FEMORAL OFFSET GUIDE PLACED THE POSITIONS OF 2 O'CLOCK AND 10 O'CLOCK FOR LEFT AND RIGHT KNEES, RESPECTIVELY. TRANSTIBIAL DRILLING OF THE FEMUR AT THE CORRECT POSITION TO DEPTH OF 30 MM. USING THE (MITEK) TRANSTIBIAL CROSS-PIN GUIDE, TWO CROSS-PIN LOCKING HOLES WERE FASHIONED FROM THE LATERAL ASPECT OF THE FEMUR TO FIX FEMORAL END OF THE GRAFT WITH TWO RIGIDFIX CROSS-PINS (MITEK) ONCE THE GRAFT HAD BEEN DRAWN INTO THE FEMORAL TUNNEL TO A DEPTH OF 30 MM. AFTER TENSIONING, THE TIBIAL END OF THE GRAFT WAS FIXED WITH A BIOABSORBABLE SCREW. THE DEVICE INVOLVED: (RIGIDFIX CROSSPIN MITEK JOHNSON & JOHNSON). COMPLICATIONS MENTIONED IN THE STUDY: ONE PATIENT IN 4- SHG GROUP FELT PARAESTHESIA ON THE MEDIAL SIDE OF THE KNEE RECOVERED AROUND 9 MONTHS POSTOPERATIVELY, ONE PATIENT IN (4-SHG) GROUP DEVELOPED TYPE 2 ARTHROFIBROSIS THAT "REQUIRED" ARTHROSCOPIC LYSIS AND PATIENT ACHIEVED FULL KNEE FLEXION WITH LOSS OF LAST 5- 10° OF EXTENSION. MEAN SIDE-TO-SIDE DIFFERENCE WITH KT-1000 WAS 1.1 ± 0.3 MM AND 2.5 ± 0.5 MM IN LARS® GROUP AND (4-SHG) GROUP, RESPECTIVELY (P=0.013). THE STUDY INDICATES THAT EARLY RESULTS OF AUGMENTING: SHORT LENGTH OR SMALL DIAMETER HARVESTED HAMSTRING TENDONS WITH LARS IN ACL RECONSTRUCTION PROVIDES SATISFACTORY, COMPARABLE RESULTS AND DISPLAYED HIGHER KNEE STABILITY COMPARED TO (4-SHG) GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943721 UNKNOWN RIGIDFIX CROSS PIN SOFT-TISSUE ANCHOR, BIOABSORBABLE HTY DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention