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

Model Number	IMPLANT SYS, BIOCOMP ACHILLES SPEEDBRIDGE W/JUMPSTART
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	01/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was requested for evaluation but was not returned therefore the complainant's event could not be verified.The devices were reported to have been sent out for cultures by facility.This device is supplied sterile.Based on the information provided, a definitive cause for the post-operative infection could not be determined.The most likely cause for this type of event is a nosocomial source or patient non-compliance with post-op wound care directions.
Event or Problem Description
It was reported that a patient had undergone an achilles speedbridge procedure on (b)(6) 2018 during which a bio-composite achilles speedbridge with jumpstart implant system, ar-8928bcj-cp (lot 10158865), was implanted.7-10 days post op the patient tested positive for staph infection.Patient was prescribed on round of iv antibiotics, but symptoms were still present.Surgeon decided to perform a second surgery which took place on (b)(6) 2019.The second procedure was performed at a different facility by the same surgeon who performed the original procedure.During the second surgery the surgeon explanted the fibertape and tigertape which are components of the ar-8928bcj-cp bio-composite achilles speedbridge with jumpstart implant system.The bio-composite anchors from the implant system were not explanted and remain in the patient.No devices were implanted during the second surgery.

• Brand Name: IMPLANT SYSTEM BIO-COMP. ACHILLES SPEED BR
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8305828
• Report Number: 1220246-2019-00878
• Device Sequence Number: 59563
• Product Code: MAI
• UDI-Device Identifier: 00888867041738
• UDI-Public: 00888867041738
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2019

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: 05/31/2019
• Device Model Number: IMPLANT SYS, BIOCOMP ACHILLES SPEEDBRIDGE W/JUMPSTART
• Device Catalogue Number: AR-8928BCJ-CP
• Device Lot Number: 10158865
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 02/05/2019
• 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