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

Model Number	PFX-426
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
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 or Problem 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
• Common Device Name: PIP FIX
• Manufacturer (Section D): HAND BIOMECHANICS LAB, INC.; 77 scripps drive, suite 104; sacramento CA 95825
• MDR Report Key: 8608748
• Report Number: 2919128-2019-00005
• Device Sequence Number: 16692611
• Product Code: JEC
• UDI-Device Identifier: 00861994000243
• UDI-Public: (01)00861994000243(17)250801(10)PFX-118-141A
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K181192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2025
• Device Model Number: PFX-426
• Device Catalogue Number: PFX-426
• Device Lot Number: PFX-118-141A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 05/14/2019
• 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: 17 YR