BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGIT WIDGET

    MDR report key: 24622159 · Received March 17, 2026

    Report

    Report Number
    2919128-2026-00002
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    March 6, 2026
    Report Date
    March 16, 2026
    Manufacturer
    HAND BIOMECHANICS LAB
    Product Code
    JDW
    PMA / PMN Number
    K992970
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS SUBMITTED TO CORRECT DEVICE INFORMATION PREVIOUSLY REPORTED IN ERROR. THE DEVICE WAS INCORRECTLY IDENTIFIED AS REUSABLE AND THE LABELED-FOR-SINGLE-USE FIELD WAS NOT COMPLETED IN THE INITIAL REPORT. THE DEVICE IS LABELED FOR SINGLE USE AND IS INTENDED FOR SINGLE-USE ONLY. THERE ARE NO CHANGES TO THE EVENT DESCRIPTION, PATIENT OUTCOME, OR DEVICE EVALUATION. HAND BIOMECHANICS LAB (HBL) BECAME AWARE OF THE EVENT ON (B)(6) 2026 DURING A FOLLOW-UP COMMUNICATION WITH THE PATIENT REGARDING TREATMENT WITH THE DIGIT WIDGET DEVICE (CATALOG NO. DWD-232). THE PATIENT REPORTED NOTICING REDNESS AROUND THE UPPER SCREW SITE AND STATED THAT THE TREATING PHYSICIAN PRESCRIBED ANTIBIOTICS. THE PATIENT FURTHER REPORTED THAT THE REDNESS RESOLVED AFTER BEGINNING ANTIBIOTIC THERAPY. THE EVENT WAS INITIALLY RECEIVED ON (B)(6) 2026 AS CUSTOMER FEEDBACK DESCRIBING A BURNING SENSATION IN THE PATIENT'S FINGERTIP WHILE USING THE DEVICE. THE TREATING PHYSICIAN EVALUATED THE PATIENT AND ATTRIBUTED THE SYMPTOMS TO TRANSIENT NERVE AGGRAVATION RELATED TO THE PATIENT'S PRIOR SURGICAL HISTORY. TREATMENT CONTINUED WITH ADJUSTED BAND USAGE. FOLLOW-UP INFORMATION WAS OBTAINED FROM THE TREATING PHYSICIAN ON (B)(6), 2026. THE PHYSICIAN CONFIRMED THAT THE SCREWS WERE REMOVED AS PLANNED AND DID NOT REQUIRE PREMATURE REMOVAL. THE SCREWS AND DEVICE COMPONENTS APPEARED NORMAL UPON REMOVAL. THE PHYSICIAN FURTHER REPORTED THAT THE PATIENT WAS NOT EXPERIENCING REDNESS, SWELLING, PAIN, OR DRAINAGE AT THE TIME OF REMOVAL AND THAT HEALING WAS PROGRESSING AS EXPECTED. THE PHYSICIAN CONFIRMED THAT THE DEVICE FUNCTIONED AS INTENDED. HBL'S INVESTIGATION DID NOT IDENTIFY ANY DEVICE MALFUNCTION. THE LOT NUMBER AND IMPLANT DATE WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. HBL WILL SUBMIT SUPPLEMENTAL INFORMATION IF ADDITIONAL DETAILS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    HAND BIOMECHANICS LAB (HBL) BECAME AWARE OF THE EVENT ON (B)(6) 2026 DURING A FOLLOW-UP COMMUNICATION WITH THE PATIENT REGARDING TREATMENT WITH THE DIGIT WIDGET DEVICE (CATALOG NO. DWD-232). THE PATIENT REPORTED NOTICING REDNESS AROUND THE UPPER SCREW SITE AND STATED THAT THE TREATING PHYSICIAN PRESCRIBED ANTIBIOTICS. THE PATIENT FURTHER REPORTED THAT THE REDNESS RESOLVED AFTER BEGINNING ANTIBIOTIC THERAPY. THE EVENT WAS INITIALLY RECEIVED ON (B)(6) 2026 AS CUSTOMER FEEDBACK DESCRIBING A BURNING SENSATION IN THE PATIENT'S FINGERTIP WHILE USING THE DEVICE. THE TREATING PHYSICIAN EVALUATED THE PATIENT AND ATTRIBUTED THE SYMPTOMS TO TRANSIENT NERVE AGGRAVATION RELATED TO THE PATIENT'S PRIOR SURGICAL HISTORY. TREATMENT CONTINUED WITH ADJUSTED BAND USAGE. FOLLOW-UP INFORMATION WAS OBTAINED FROM THE TREATING PHYSICIAN ON (B)(6) 2026. THE PHYSICIAN CONFIRMED THAT THE SCREWS WERE REMOVED AS PLANNED AND DID NOT REQUIRE PREMATURE REMOVAL. THE SCREWS AND DEVICE COMPONENTS APPEARED NORMAL UPON REMOVAL. THE PHYSICIAN FURTHER REPORTED THAT THE PATIENT WAS NOT EXPERIENCING REDNESS, SWELLING, PAIN, OR DRAINAGE AT THE TIME OF REMOVAL AND THAT HEALING WAS PROGRESSING AS EXPECTED. THE PHYSICIAN CONFIRMED THAT THE DEVICE FUNCTIONED AS INTENDED. HBL'S INVESTIGATION DID NOT IDENTIFY ANY DEVICE MALFUNCTION. THE LOT NUMBER AND IMPLANT DATE WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. HBL WILL SUBMIT SUPPLEMENTAL INFORMATION IF ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 0

    A PATIENT USING THE DIGIT WIDGET DEVICE REPORTED REDNESS AROUND THE UPPER SCREW SITE. THE TREATING PHYSICIAN PRESCRIBED ANTIBIOTICS. THE PATIENT REPORTED THAT THE REDNESS RESOLVED AFTER ANTIBIOTIC TREATMENT. THE SCREWS WERE LATER REMOVED AS PLANNED.

    Description of Event or Problem · 0

    A PATIENT USING THE DIGIT WIDGET DEVICE REPORTED REDNESS AROUND THE UPPER SCREW SITE. THE TREATING PHYSICIAN PRESCRIBED ANTIBIOTICS. THE PATIENT REPORTED THAT THE REDNESS RESOLVED AFTER ANTIBIOTIC TREATMENT. THE SCREWS WERE LATER REMOVED AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682640 DIGIT WIDGET DIGIT WIDGET JDW HAND BIOMECHANICS LAB DWD-232 UNKOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown Required Intervention