MAUDE Adverse Event Report: ARTHREX, INC. IMPL DELIVERY SYS,DISTAL BICEPS REPR; PLATE, FIXATION, BONE

Model Number	IMPL DELIVERY SYS,DISTAL BICEPS REPR
Health Effect - Clinical Codes	Purulent Discharge (1812); Post Operative Wound Infection (2446)
Date of Event	06/11/2018
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 remains in patient and was not returned for evaluation therefore the complainant's event could not be verified.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
It was reported that the patient underwent an right distal biceps tendon repair procedure on (b)(6) 2018 where an arthrex distal biceps repair system, ar-2260, was used.On (b)(6) 2018, the patient reported via phone call to his physician's office that he noticed "the incision looking red and some yellow drainage coming from the incision".The patient was then prescribed a course of augmentin by physician.At this point in time, the surgeon will not perform a second surgery.

• Brand Name: IMPL DELIVERY SYS,DISTAL BICEPS REPR
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7642839
• Report Number: 1220246-2018-00532
• Device Sequence Number: 2376563
• Product Code: HRS
• UDI-Device Identifier: 00888867026476
• UDI-Public: 00888867026476
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K062747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/27/2018

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 Expiration Date: 02/28/2023
• Device Model Number: IMPL DELIVERY SYS,DISTAL BICEPS REPR
• Device Catalogue Number: AR-2260
• Device Lot Number: F195488
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 06/27/2018
• 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