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

Model Number	DWD-232
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Bacterial Infection (1735)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reviewed sterilization and sterile barrier inspection records for probable lot.No pattern related to irradiation dose lot or device lot was noted.Confirmed labeling included cautions regarding pin site care.
Event or Problem Description
Patient had surgery to install the digit widget external fixation system.Physician reported, "patient developed pin tract infection and required early removal of device, is on humira for pa and immunosuppressed." device removed after 8 weeks of treatment.
Event or Problem Description
Patient had surgery to install the digit widget external fixation system.Physician reported, "patient developed pin tract infection and required early removal of device, is on humira for pa and immunosuppressed." device removed after 8 weeks of treatment.
Additional Manufacturer Narrative
Reviewed sterilization and sterile barrier inspection records for probable lot.No pattern related to irradiation dose lot or device lot was noted.Confirmed labeling included cautions regarding pin site care.

• Brand Name: DIGIT WIDGET
• Common Device Name: DIGIT WIDGET
• Manufacturer (Section D): HAND BIOMECHANICS LAB, INC.; 77 scripps drive, suite 104; sacramento CA 95825
• MDR Report Key: 7654928
• Report Number: 2919128-2018-00023
• Device Sequence Number: 124087
• Product Code: JDW
• UDI-Device Identifier: 00861994000212
• UDI-Public: (01)00861994000212(10)DWD-117-047B
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K992970
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

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-117-047B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 07/02/2018
• Supplement Report FDA Received Date: 12/28/2018
• 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: 25 YR