MAUDE Adverse Event Report: ARTHREX INC. IMPLANT SYS, BIOCOMP. ACHILLES SPEEDBRIDGE W/JUMP; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	AR-8928BCJ-CP
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091); Reaction (2414)
Date of Event	03/29/2018
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.Device history record review revealed nothing relevant to this event.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.The potential causes of this event are being 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 according to the surgeon the patient has had a reaction to the material and is having a revision done.Representative did not have all details at the time of the initial report because the revision had not started yet at the time of the report.Follow-up investigation: the explanted device has been confirmed to be ar-8928bcj-cp, lot 10129351.Original surgery took place (b)(6) 2017.Approximately (b)(6) 2017 the patient began to experience pain, sensitivity, swelling and tightness which continued through march.On (b)(6) 2018 the patient's original surgery repair had healed and the patient underwent a revision procedure.The surgeon removed the original implant and flushed the area out.Both procedures took place at the same facility.

• Brand Name: IMPLANT SYS, BIOCOMP. ACHILLES SPEEDBRIDGE W/JUMP
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7439297
• Report Number: 1220246-2018-00137
• Device Sequence Number: 19122827
• Product Code: MAI
• UDI-Device Identifier: 00888867251991
• UDI-Public: 00888867251991
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 04/18/2018

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: 02/01/2019
• Device Catalogue Number: AR-8928BCJ-CP
• Device Lot Number: 10129351
• 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: 03/29/2018
• Initial Report FDA Received Date: 04/18/2018
• 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