MAUDE Adverse Event Report: ARTHREX, INC. SUTURETAPE, 1.3MM W/NEEDLE, WHITE/BLUE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	SUTURETAPE, 1.3MM W/NEEDLE, WHITE/BLUE
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930); Inflammation (1932); Swelling (2091)
Date of Event	03/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an acl reconstruction procedure on (b)(6) 2019 where the following devices were implanted: ar-1349m / lot: 10253224 / qty: 1 ar-1355 / lot: 10216387 / qty: 1 ar-7500 / lot: 100038 / qty: 2 after the surgery, infection of resident bacteria was observed around the post screw on the tibial side.Whether the sterilization and procedures of instruments used for surgery were appropriate is currently under investigation by the facility.Additional information has been requested.Additional information provided (b)(6) 2019: one day after the procedure, the patient experienced 38°c fever.3 days after, the patient experienced mild swelling of lower right thigh proximal part.5 days after, the patient experienced 39 degree fever.Blood was taken and inflammatory response was high.

• Brand Name: SUTURETAPE, 1.3MM W/NEEDLE, WHITE/BLUE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8500871
• Report Number: 1220246-2019-01037
• Device Sequence Number: 11244857
• Product Code: GAT
• UDI-Device Identifier: 00888867229228
• UDI-Public: 00888867229228
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171296
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2019

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: 11/30/2023
• Device Model Number: SUTURETAPE, 1.3MM W/NEEDLE, WHITE/BLUE
• Device Catalogue Number: AR-7500
• Device Lot Number: 100038
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 04/10/2019
• 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