MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,BIO-COMP S-TAK SM JNT; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	SUTR ANCH,BIO-COMP S-TAK SM JNT
Health Effect - Clinical Code	Osteomyelitis (4533)
Date of Event	04/28/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that the patient had a right ankle arthroscopy with debridement and lateral ligament reconstruction.; date of surgery was (b)(6) 2021.The patient has developed an infection at the site.This was seen by the surgeon at a follow up appointment.The patient is male, (b)(6) years and presented with osteomyelitis; he is being treated with antibiotics and is doing well to date.There are no plans to remove the implant.

• Brand Name: SUTR ANCH,BIO-COMP S-TAK SM JNT
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11842389
• Report Number: 1220246-2021-03108
• Device Sequence Number: 19769991
• Product Code: MAI
• UDI-Device Identifier: 00888867050365
• UDI-Public: 00888867050365
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/18/2021

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: 10/31/2024
• Device Model Number: SUTR ANCH,BIO-COMP S-TAK SM JNT
• Device Catalogue Number: AR-8934BCNF
• Device Lot Number: 12169240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/18/2021
• 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