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

Model Number DWD-232

Device Problems Defective Component (2292); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/30/2022

Event Type  Injury  

Manufacturer Narrative

Hospital did not comply with surgeons wishes and disposed to drill guide.Efforts to obtain x-rays to facilitate our investigation failed.

Event Description

Patient had surgery to install a digit widget external fixation system.Surgeon called to report he was unable to install the distal bone pin due to an obstruction in the drill guide tube.He said x-rays showed an "occluded hole" and the object looked like a drill bit.Surgeon was able to completed the case with parts from a 2nd digit widget system.

• 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: 14547699
• MDR Text Key: 292974188
• Report Number: 2919128-2022-00002
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 00861994000212
• UDI-Public: (01)00861994000212(17)310901(10)DWD-121-105A
• 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: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• 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
• Device Lot Number: DWD-121-105A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2022
• 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