BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24410857 · Received February 22, 2026

    Report

    Report Number
    1220246-2026-00800
    Event Type
    Injury
    Date Received
    February 22, 2026
    Date of Event
    July 1, 2010
    Report Date
    February 22, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ON 23 JAN 2026, ARTHREX WAS NOTIFIED VIA EMAIL OF A CASE STUDY PUBLISHED IN JULY 2010 BY THE JOURNAL OF SHOULDER ELBOW SURG TITLED ¿COMPLICATIONS ASSOCIATED WITH SUBPECTORAL BICEPS TENODESIS: LOW RATES OF INCIDENCE FOLLOWING SURGERY.¿ THE STUDY REVIEWED 373 PATIENTS AND IDENTIFIED BICEPS TENDON LESION WITH THE BIOABSORBABLE INTERFERENCE SCREWS AND TENODESIS SCREWS IN 4 PATIENTS DURING THE UNKNOWN FOLLOW-UP PERIOD. 1 PATIENT EXPERIENCED AN INFECTION. REF: NHO SJ, REIFF SN, VERMA NN, SLABAUGH MA, MAZZOCCA AD, ROMEO AA. COMPLICATIONS ASSOCIATED WITH SUBPECTORAL BICEPS TENODESIS: LOW RATES OF INCIDENCE FOLLOWING SURGERY. J SHOULDER ELBOW SURG. JUL 2010;19(5):764-8. DOI:10.1016/J.JSE.2010.01.024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471499 UNK SCREW, FIXATION, BONE HWC ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown