BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MINI ANCHOR

    MDR report key: 9134526 · Received September 30, 2019

    Report

    Report Number
    1221934-2019-58667
    Event Type
    Injury
    Date Received
    September 30, 2019
    Report Date
    September 17, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: C. AGOUT, ET AL 2017, ¿CHRONIC INSTABILITY OF THE THUMB METACARPO-PHALANGEAL JOINT: SEVEN-YEAR OUTCOMES OF THREE SURGICAL TECHNIQUES¿, ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH, VOL. 103, PAGES 923-926 (FRANCE). THE OBJECTIVE OF THIS STUDY WAS TO COMPARE THE CLINICAL OUTCOMES OF THE THREE MAIN SURGICAL TECHNIQUES USED TO TREAT CHRONIC TMCPJ INSTABILITY. THIS SINGLE-CENTRE RETROSPECTIVE STUDY INCLUDED ALL PATIENTS MANAGED SURGICALLY BETWEEN 2000 AND 2012 FOR CHRONIC POST-TRAUMATIC TMCPJ INSTABILITY USING ANY OF THE THREE FOLLOWING TECHNIQUES: PRIMARY REPAIR, LIGAMENT RECONSTRUCTION, AND ARTHRODESIS. SUBJECTIVE AND OBJECTIVE OUTCOMES AND COMPLICATION RATES AT LAST FOLLOW-UP WERE COMPARED ACROSS THESE THREE TECHNIQUES. TREATMENT INDICATIONS WERE AS FOLLOWS. WHEN THE COLLATERAL LIGAMENT SEEMED REPARABLE, THE DISTAL FIBROUS SCAR TISSUE WAS REMOVED AND THE LIGAMENT REATTACHED TO AN ANCHOR (MICROFIX QUICK ANCHOR, DEPUY MITEK INC., JOHNSON AND JOHNSON CO., (B)(4), USA). IN PATIENTS WITH IRREDUCIBLE SUBLUXATION AND/OR CARTILAGE LESIONS, ARTHRODESIS AT 15°-20° OF FLEXION WAS PERFORMED AND FIXED BY TWO LONGITUDINAL K-WIRES STABILISED BY FIGURE-OF-8 TENSION BAND WIRING. OF 67 INCLUDED PATIENTS. 55 WERE RE-EVALUATED, AFTER A MEAN FOLLOW-UP OF 84 MONTHS (RANGE: 24-164 MONTHS). AMONG THEM, 48 (87.3%) WERE SATISFIED OR VERY SATISFIED WITH THE OUTCOME. PAIN RELIEF WAS SIGNIFICANTLY BETTER IN THE ARTHRODESIS GROUP. MEAN QUICK-DASH SCORES WERE 17.4 (RANGE: 0.0-89.5) WITH PRIMARY REPAIR, 25.7 (RANGE: 0.0-58.3) WITH LIGAMENT RECONSTRUCTION, AND 17.8 (RANGE: 0.0-50.0) WITH ARTHRODESIS. MEAN PINCH-TEST STRENGTH COMPARED TO THE NORMAL SIDE WAS 89% WITH PRIMARY REPAIR, 84% WITH LIGAMENT RECONSTRUCTION, AND 94% WITH ARTHRODESIS. IN THE LIGAMENT RECONSTRUCTION GROUP, 6 OF THE 10 PATIENTS HAD INSTABILITY AT LAST FOLLOW-UP AND THE PROPORTION OF PATIENTS DESCRIBING THEMSELVES AS FULLY RECOVERED WAS SIGNIFICANTLY SMALLER THAN IN THE OTHER GROUPS. FOUR FAILURES WERE RECORDED AT LAST FOLLOW-UP. THE DEVICE INVOLVED: (MICROFIX QUICK ANCHOR, DEPUY MITEK INC., JOHNSON AND JOHNSON CO., (B)(4), USA). COMPLEX REGIONAL PAIN SYNDROME TYPE 1 DEVELOPED IN 7 PATIENTS: 2 OF 20 (10%) IN THE PRIMARY REPAIR GROUP, 3 OF 10 (30%) IN THE LIGAMENT RECONSTRUCTION GROUP, AND 2 OF 25 (8%) IN THE ARTHRODESIS GROUP. ALL 7 PATIENTS HAD ACHIEVED A FULL RECOVERY AT LAST FOLLOW-UP. TREATMENT FAILURE WITH PERSISTENT SYMPTOMATIC INSTABILITY OCCURRED IN 4 PATIENTS: 1 IN THE PRIMARY REPAIR GROUP, 2 IN THE LIGAMENT RECONSTRUCTION GROUP, AND 1 IN THE ARTHRODESIS GROUP. THIS LAST PATIENT HAD FAILED TO COMPLY WITH POST-OPERATIVE CARE INSTRUCTIONS. ALL 4 PATIENTS WERE MANAGED BY REVISION TMCPJ ARTHRODESIS. SURGERY TO TREAT CHRONIC TMCPJ INSTABILITY PRODUCES GOOD OUTCOMES. PRIMARY REPAIR DESERVES PREFERENCE WHENEVER POSSIBLE. IN CONTRAST TO PREVIOUS REPORTS, OUTCOMES AFTER LIGAMENT RECONSTRUCTION WERE NOT BETTER COMPARED TO ARTHRODESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928514 UNKNOWN MINI ANCHOR SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE HWC DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R