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

Model Number DWD-232

Device Problem Insufficient Information (3190)

Patient Problem Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Use of the word impingement implies the device affected the adjacent fingers through contact.The digit widget is installed on the dorsal aspect of the finger with no portion extending to the radial, ulnar, or palmar sides so contact should not be possible.It is unclear what could have allowed the device to affect the adjacent fingers based on the information provided.

Event Description

Article 'preliminary soft-tissue distraction versus checkrein ligament release after fasciectomy in the treatment of dupuy ren proximal interphalangeal joint contractures' published plastic and reconstructive surgery, vol.128, no.5, november 2011.On page 1111 it was reported that "one digit widget was removed early because of impingement on an adjacent digit".

• Brand Name: DIGIT WIDGET
• Type of Device: DIGIT WIDGET
• Manufacturer (Section D): HAND BIOMECHANICS LAB, INC.; 77 scripps drive, suite 104; sacramento CA 95825
• Manufacturer (Section G): HAND BIOMECHANICS LAB, INC.; 77 scripps drive, suite 104; sacramento CA 95825
• Manufacturer Contact: dustin dequine ; 77 scripps drive, suite 104; sacramento, CA 95825 ; 9169235073
• MDR Report Key: 8203134
• MDR Text Key: 131620598
• Report Number: 2919128-2018-00028
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992970
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DWD-232
• Device Catalogue Number: DWD-232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention