Digit Widget

Description of Event or Problem

The patient reported swelling and mild discomfort around the Digit Widget pin sites after approximately seven weeks of treatment. The condition subsequently progressed to a pin-site infection requiring antibiotic treatment. Per the patient's healthcare provider, extension torque was temporarily discontinued while the infection was treated. The patient later reported that the infection had cleared and Digit Widget treatment was resumed without recurrence of the infection.

Additional Manufacturer Narrative

HBL reviewed the information provided regarding the reported pin-site infection. No device malfunction, breakage, loss of fixation, or product nonconformity was reported. The patient received antibiotic treatment and temporarily discontinued extension torque per the healthcare provider's instructions. Follow-up confirmed that the infection resolved and the patient resumed Digit Widget treatment without recurrence of the infection. Pin-site infection is a known risk associated with the use of external fixation devices. Based on the information available, no device-related malfunction or product deficiency was identified as contributing to the reported event