MAUDE Adverse Event Report: HAND BIOMECHANICS LAB, INC. DIGIT WIDGET

Model Number	DWD-232
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Granuloma (1876)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analyzed component acceptance and production records, performed historical data analysis and trend analysis.No trend related to irradiation dose lot, component lot or device lot was noted.Confirmed labeling included cautions regarding pin site care.
Event or Problem Description
Patient had surgery to install a digit widget external fixation system.Physician reported 50 days post operative that 'patient has developed a granuloma at the distal pin', that the site was not infected, and 'will address the granuloma with silver nitrate'.

• Brand Name: DIGIT WIDGET
• Common Device Name: DIGIT WIDGET
• Manufacturer (Section D): HAND BIOMECHANICS LAB, INC.; 77 scripps drive, suite 104; sacramento CA 95825
• MDR Report Key: 11343770
• Report Number: 2919128-2021-00003
• Device Sequence Number: 14304969
• Product Code: JDW
• UDI-Device Identifier: 00861994000212
• UDI-Public: (01)00861994000212(17)300501(10)DWD-120-045A
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K992970
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: DWD-232
• Device Catalogue Number: DWD-232
• Device Lot Number: DWD-120-045A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR