MAUDE Adverse Event Report: ARTHREX, INC. PROXIMAL TENODESIS IMPLANT SYSTEM REV: 0; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number PROXIMAL TENODESIS IMPLANT SYSTEM REV: 0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Swelling (2091)

Event Date 10/03/2018

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The device remains in the patient.The root cause of the event could not be determined from the information available and without device evaluation.Follow up information has been requested but no response has been received as of time of this report.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 Description

It was reported that a patient is having an adverse reaction after having ar-2290 (lot: 1022169) and a cadaver bone graft implanted during a procedure that took place on (b)(6) 2018.The patient noticed a rash around the surgical site on (b)(6) 2018, ten days after the procedure.The patient's rash around the surgical site was very red, itchy, raised, swollen and hot to the touch.The patient had a follow up visit with their surgeon, and had a visit with their primary physician.The primary physician told the patient that they are experiencing an adverse reaction, and to continue to monitor the symptoms.Allergen testing has not been done as of (b)(6) 2018, and the patient has another follow-up visit scheduled with their surgeon on (b)(6) 2019.The patient has been treating the symptoms with benadryl.The patient stated that they are allergic to certain metals.Additional information has been requested.

• Brand Name: PROXIMAL TENODESIS IMPLANT SYSTEM REV: 0
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 8263770
• MDR Text Key: 133701407
• Report Number: 1220246-2019-00857
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867026698
• UDI-Public: 00888867026698
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2019

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 Expiration Date: 04/30/2023
• Device Model Number: PROXIMAL TENODESIS IMPLANT SYSTEM REV: 0
• Device Catalogue Number: AR-2290
• Device Lot Number: 10222169
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/27/2018
• Initial Date FDA Received: 01/21/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/06/2018
• 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): Other