DIGIT WIDGET

Additional Manufacturer Narrative

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.

Description of Event or Problem

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.

Additional Manufacturer Narrative

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

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.