BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MINI ANCHOR

    MDR report key: 9233080 · Received October 24, 2019

    Report

    Report Number
    1221934-2019-59185
    Event Type
    Injury
    Date Received
    October 24, 2019
    Report Date
    October 21, 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. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN ANCHOR DEVICES. 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 IS REPORT 3 OF 3 FOR THE SAME EVENT. THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: GALLINET D., (2011), SUTURE ANCHOR REINSERTION OF DISTAL BICEPS RUPTURE: CLINICAL RESULTS AND RADIOLOGICAL ASSESSMENT OF TENDON HEALING, ORTHOPAEDICS AND TRAUMATOLOGY: SURGERY AND RESEARCH, VOLUME 97, PAGES 252-259 ( FRANCE). THIS STUDY EMPHASIZES TO ANALYZED CLINICAL RESULTS WITH SUTUREANCHOR REINSERTION IN DISTAL BICEPS BRACHII TENDON RUPTURE. THE PATIENTS EVALUATED ON COURSE OF THIS STUDY: BETWEEN 2003 AND 2008, A TOTAL OF 27 PATIENTS, ALL MALES, MEAN AGE, 49 YEARS (RANGE, 36-60 YRS) WHO PRESENTED WITH TRAUMATIC RUPTURE OF THE DISTAL BICEPS BRACHII TENDON, REINSERTED TO THE RADIAL TUBEROSITY BY SUTURE ANCHOR USING A SINGLE SURGICAL TECHNIQUE WERE RETROSPECTIVELY REVIEWED. TYPES OF SUTURE ANCHORS USED WERE SLOW RESORPTION PANALOK 3.5 MM (DEPUY MITEK®) , NON-RESORBABLE, HIGH MECHANICAL RESISTANCE GLL QUICKANCHOR 2.4 MM (DEPUY MITEK®), NON-RESORBABLE, HIGH MECHANICAL RESISTANCE SUPER QUICKANCHOR 2.9 MM (DEPUY MITEK®) AND TWO OTHER COMPETITORS SUTRE ANCHOR TYPE. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: TWO PATIENTS SHOWED VERY THIN INSERTION WITHOUT RADIAL TUBEROSITY OSSIFICATION AND 1 (WITH THE LONGEST INTERVAL TO SURGERY) HAD AN ITERATIVE RUPTURE, AND THESE RESULTS (11%) WERE CONSIDERED POOR. EIGHT PATIENTS HAD SHOWN -5° TO -20° SUPINATION LOSS. 10 (35%) SHOWED RADIAL TUBEROSITY OSSIFICATION FACING THE ANCHORAGES. SEVEN (19%) SHOWED INTRATENDON OSSIFICATION WITHOUT CONTACT WITH THE RADIAL TUBEROSITY (OR RADIAL TUBEROSITY OSSIFICATION). MODERATE AND POOR REINSERTION: FORCE 77% OF CONTRALATERAL (P<0.05). THIS REPORT IS FOR AN UNKNOWN MITEK SLOW RESORPTION PANALOK, UNKNOWN MITEK NON-RESORBABLE, HIGH MECHANICAL RESISTANCE GLL QUICKANCHOR AND UNKNOWN MITEK NON-RESORBABLE SUPER QUICKANCHO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1025833 UNKNOWN MINI ANCHOR SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE HWC DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention