MAUDE Adverse Event Report: ARTHREX, INC. IMPL SYS,BIO-COMP ACHILLES MID-SUBSTANCE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	AR-8929BC-CP
Health Effect - Clinical Codes	Inflammation (1932); Swelling (2091); Test Result (2695)
Date of Event	07/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.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 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.Lot number was not provided so device history record review cannot be performed.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that the patient is a year out from her surgery that involved a speedbridge.She was inquiring if the speedbridge was a bio product or a bio-composite product.Follow up investigation: it was reported that the patient is a year out from her resection of retro calcaneal spur and haglund deformity with detachment and reattachment of achilles tendon on the right foot.The patient is experiencing swelling over the surgical area and also has some elevated titer's that may be showing an inflammatory response.

• Brand Name: IMPL SYS,BIO-COMP ACHILLES MID-SUBSTANCE
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6724219
• Report Number: 1220246-2017-00276
• Device Sequence Number: 11008738
• Product Code: MAI
• UDI-Device Identifier: 00888867131651
• UDI-Public: 00888867131651
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 07/20/2017

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 Catalogue Number: AR-8929BC-CP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 07/19/2017
• 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