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

Model Number DWD-232

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

Analyzed production records, performed historical data analysis and trend analysis.No trend related to irradiation dose lot or possible device lost were noted.Confirmed labeling included cautions regarding pin site care.

Event Description

Patient had surgery to install a digit widget external fixation system.The occupational therapist reported that patient presented with infection at 3 weeks.Antibiotics were prescribed.

• 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: 8120254
• MDR Text Key: 128906705
• Report Number: 2919128-2018-00030
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2018
• 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: 11/02/2018
• 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