MAUDE Adverse Event Report: ARTHREX, INC. PLANTAR LAPIDUS PLATE, STANDARD RIGHT; PLATE, FIXATION, BONE

Model Number	PLANTAR LAPIDUS PLATE, STANDARD RIGHT
Health Effect - Clinical Codes	Swelling (2091); Impaired Healing (2378); Skin Inflammation (2443)
Date of Event	04/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.The device remains in the patient.The cause of the event could not be determined from the information available and without device evaluation.A possible cause of this type of event may be a reaction of the patient to the material(s) implanted or used during the implant procedure.Product directions for use warns of effects like foreign body and allergic-like reactions as well as infections both deep and superficial to the implant materials.Patient sensitivity to materials must be considered prior to implantation.
Event or Problem Description
A patient reported that she underwent a plantar lapidus procedure on her right foot on (b)(6) 2018.Since her surgery patient has been experiencing what she feels may be possible reaction symptoms in and around the surgical site which include: slow wound healing, redness, rough skin, swelling and inflammation which flares up worse at times.Patient stated that there is no infection.Patient has plans to go to an allergist for allergy testing to the materials which comprise her arthrex implants.The following arthrex devices were implanted during the (b)(6) 2018 surgery: ar-8941pr plate (qty 1), ar-8935-24 cortical screw (qty 1), ar-8935-22 cortical screw (qty 1), ar-8935-28 cortical screw (qty 1) and ar-8935-18 cortical screw (qty 2).Devices are titanium and patient has been provided the material composition breakdown of the astm titanium standards of the device material.

• Brand Name: PLANTAR LAPIDUS PLATE, STANDARD RIGHT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7861351
• Report Number: 1220246-2018-00634
• Device Sequence Number: 13771075
• Product Code: HRS
• UDI-Device Identifier: 00888867132269
• UDI-Public: 00888867132269
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K111253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2018

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: PLANTAR LAPIDUS PLATE, STANDARD RIGHT
• Device Catalogue Number: AR-8941PR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/10/2018
• 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: Other