MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH MINI BC S-TAK 2.4X 8.5MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SUTR ANCH MINI BC S-TAK 2.4X 8.5MM
Health Effect - Clinical Codes	Purulent Discharge (1812); Foreign Body Reaction (1868); Unspecified Infection (1930); Staphylococcus Aureus (2058); Impaired Healing (2378)
Date of Event	08/08/2020
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 root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that arthrex mexico has been notified of the following incident: a patient underwent an arthroscopic brostrom and internal brace ankle procedure (b)(6) 2019.The patient progressed erroneously in wound healing, secondary to rejection of internal suture material, causing infection and desistance on (b)(6) 2020.Patient has been under antibiotic treatment since with biomics 400mg and danzen 10mg.On (b)(6) 2020 a fistulectomy was performed in the surgeon¿s office under local anesthesia, as well as wound remodeling and closure with dermalon 3/0, which was rejected and (b)(6) 2020 a vacuum therapy peak wound patch was placed to prevent the formation of seroma which prevents proper wound closure in an attempt to avoid a major surgical procedure.After 10 days the patch was removed (b)(6) 2020 finding granulation of the tissue, with bleeding edges and pacacity of wound remodeling with little exudate.A culture was performed of the secretion.Laboratory sample results reported staphylococcus aureus.Patient is sensitive to trimethoprim with sulfamethoxazole so an oral administration was administered for 15 days to remit infection symptoms.Due to wound closure not occurring a revision surgery has been scheduled for (b)(6) 2020 to remove the arthrex products and remodel the wound for cutaneous closure.

• Brand Name: SUTR ANCH MINI BC S-TAK 2.4X 8.5MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10484014
• Report Number: 1220246-2020-02135
• Device Sequence Number: 19137204
• Product Code: MAI
• UDI-Device Identifier: 00888867010147
• UDI-Public: 00888867010147
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K140855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/02/2020

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: 04/30/2021
• Device Model Number: SUTR ANCH MINI BC S-TAK 2.4X 8.5MM
• Device Catalogue Number: AR-1322BCNF
• Device Lot Number: 10311113
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 09/02/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other