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

Model Number DWD-232

Device Problems Contamination (1120); Patient Device Interaction Problem (4001)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

Reviewed sterilization and sterile barrier inspection records of lot.No pattern related to irradiation dose lot or device lot was noted confirmed labeling included cautions regarding pin site care.

Event Description

The digit widget external fixation system was reported used in article "management of flexor injuries with proximal interphalangeal joint contracture".It is written with patient #1, "at 6 weeks he developed a superficial pin site infection, which was successfully treated with 10 days of oral cephalexin".

Manufacturer Narrative

Reviewed sterilization and sterile barrier inspection records of lot.No pattern related to irradiation dose lot or device lot was noted confirmed labeling included cautions regarding pin site care.

Event Description

The digit widget external fixation system was reported used in article "management of flexor injuries with proximal interphalangeal joint contracture".It is written with patient #1, "at 6 weeks he developed a superficial pin site infection, which was successfully treated with 10 days of oral cephalexin".

• Brand Name: DIGIT WIDGET
• Type of Device: DIGIT WIDGET
• Manufacturer (Section D): HAND BIOMECHANICS LAB, INC.; 77 scripps drive, suite 104; sacramento CA 95825
• MDR Report Key: 7237477
• MDR Text Key: 98882078
• Report Number: 2919128-2018-00002
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 00861994000212
• UDI-Public: (01)00861994000212(10)DWD-116-157B
• Combination Product (y/n): N
• PMA/PMN Number: K992970
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• 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
• Device Lot Number: DWD-116-157B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR