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

Model Number	DWD-232
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Received notification of event on a device registration form 6 day post operatively.Efforts to obtain information to facilitate our investigation failed.
Event or Problem Description
Patient had surgery to install a digit widget external fixation system.Hand biomechanics lab received device registration form 6 days post operatively with comment 'bone pin distal lodged in pin block device.2nd kit used only distal pin and pin block".There is no foreseeable way for the pin to become stuck in the component hand biomechanics lab calls the 'pin block'; however, it is conceivable that the drill guide could be called a pin block by a user.This case is therefore potentially similar to cases where a nick was created in the bone pin when an adjacent pin is cut, causing a burr and preventing the drill guide from being removed from the pin.Surgeon was able to back-out the pin that was stuck and completed the case with parts from a 2nd digit widget system.

• Brand Name: DIGIT WIDGET
• Common Device Name: 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: 13734622
• Report Number: 2919128-2022-00001
• Device Sequence Number: 14643009
• Product Code: JDW
• UDI-Device Identifier: 00861994000212
• UDI-Public: (01)00861994000212(17)301101(10)DWD-112-122B
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/10/2022

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-120-122B
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female