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

Model Number	DWD-232
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although a clear conclusion about the cause of the reported adverse event could not be determined, risk analysis and historical assessment indicate most probable cause is a knicked adjacent pin.
Event or Problem Description
Patient had surgery to install a digit widget external fixation system.The surgeon emailed hand biomecanics lab 23 days post operatively and report 'the distal pin was stuck in the hole and i had to destroy the drill guide with a burr to be able to get it out.' in summary the surgeon was unable to remove the distal pin from the drill guide tube of the drill guide.

• Brand Name: DIGIT WIDGET
• Common Device Name: DIGIT WIDGET
• Manufacturer (Section D): HAND BIOMECHANICS LAB, INC.; 77 scripps drive, suite 104; sacramento, ca
• MDR Report Key: 10212514
• Report Number: 2919128-2020-00007
• Device Sequence Number: 16961573
• Product Code: JDW
• UDI-Device Identifier: 00861994000212
• UDI-Public: (01)00861994000212(17)291201(10)DWD-119-130B
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K992970
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2020

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-119-130B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2020
• Initial Report FDA Received Date: 06/30/2020
• 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: 56 YR