MAUDE Adverse Event Report: ARTHREX, INC. IMPL DELIVERY SYS,DISTAL BICEPS, BC; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	IMPL DELIVERY SYS,DISTAL BICEPS, BC
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	05/05/2016
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.The device remains in the patient.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported by an allergist's office that a patient has been referred to them for an allergic reaction.Patient had a biceps tendon repair procedure on (b)(6) 2016.During the procedure the patient received the following implant: ar-2260bc, lot 600093.The reporter has requested material composition of the patient's implant.Material composition has been provided.

• Brand Name: IMPL DELIVERY SYS,DISTAL BICEPS, BC
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8861340
• Report Number: 1220246-2019-01228
• Device Sequence Number: 19332953
• Product Code: MAI
• UDI-Device Identifier: 00888867204645
• UDI-Public: 00888867204645
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K062747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2019

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: 08/31/2017
• Device Model Number: IMPL DELIVERY SYS,DISTAL BICEPS, BC
• Device Catalogue Number: AR-2260BC
• Device Lot Number: 600093
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 08/05/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other