MAUDE Adverse Event Report: HAND BIOMECHANICS LAB, INC. PIP FIX

Model Number PFX-426

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 device lot was noted.Confirmed labeling included cautions regarding pin site care.

Event Description

Patient had surgery to install a pip fix external fixation system.Physician reported that "pin tract infection required device removal @ 4 weeks postop.".

• Brand Name: PIP FIX
• Type of Device: PIP FIX
• 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: 8608748
• MDR Text Key: 145000875
• Report Number: 2919128-2019-00005
• Device Sequence Number: 1
• Product Code: JEC
• UDI-Device Identifier: 00861994000243
• UDI-Public: (01)00861994000243(17)250801(10)PFX-118-141A
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181192
• 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: 05/14/2019

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
• Device Operator: Health Professional
• Device Model Number: PFX-426
• Device Catalogue Number: PFX-426
• Device Lot Number: PFX-118-141A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2019
• Initial Date FDA Received: 05/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2018
• 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
• Patient Age: 17 YR