MAUDE Adverse Event Report: ARTHREX INC. IMPLANT SYSTEM,BIO-COMPOSITE ACHILLES SPEEDBRIDGE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	AR-8928BC-CP
Health Effect - Clinical Codes	Edema (1820); Fall (1848); Pain (1994)
Date of Event	08/01/2017
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 device was requested for evaluation but was not returned, 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.Device history record review revealed nothing relevant to this event.A likely cause of the event is as stated in the complaint, the patient fell.The directions for use states: post-operatively, until healing is complete the fixation provided by this device should be protected.The post-operative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the implant.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
A surgeon has reported to the sales reps that the patient has reported ongoing pain in the area of the implants post achilles speedbridge surgery that was performed on (b)(6) 2016.During the procedure the bone was prepared using the drill and drill guide provided in the achilees speedbridge kit.Follow-up investigation: patient began experiencing pain 2-4 months after the (b)(6) 2016 procedure.Lot number of the ar-8928bc-cp was 10052318.Mri revealed patchy bone edema around the anchor.Patient has also developed lymph edema.Patient reported a fall.Revision procedure was performed on (b)(6) 2017 and one distal row 4.75 bio-composite swivelock anchor, from the original achilles speedbridge construct, was replaced with a 5.5 bio-composite swivelock anchor.The (b)(6) 2017 revision procedure was reported to have been performed as a result of patient fall which occurred in (b)(6) 2017.The 4.75 mm swivelock was explanted during the (b)(6) 2017 procedure because it was discovered to have been 50% pulled out.The swivelock was not broken.The explanted swivelock anchor that was explanted was disposed of at time of procedure.Since the second (b)(6) 2017 procedure patient is reported to still be experiencing pain the area of the anchors.

• Brand Name: IMPLANT SYSTEM,BIO-COMPOSITE ACHILLES SPEEDBRIDGE
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7251307
• Report Number: 1220246-2018-00032
• Device Sequence Number: 110969
• Product Code: MAI
• UDI-Device Identifier: 00888867049123
• UDI-Public: 00888867049123
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 02/08/2018

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: 06/01/2018
• Device Catalogue Number: AR-8928BC-CP
• Device Lot Number: 10052318
• 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: 01/17/2018
• Initial Report FDA Received Date: 02/08/2018
• 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