MAUDE Adverse Event Report: ARTHREX, INC. SUTURE TENSIONER/CUTTER FOR KNEES; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	SUTURE TENSIONER/CUTTER FOR KNEES
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint confirmed, evaluation by the supplier reveals a sharp edge inside the device.
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 during a knee arthroscopy procedure, the surgeon implanted a meniscal cinch ii per the technique.When pushing the knots with the suture tensioner/ cutter for 2-0 fw, ar-5815, the suture was cut.The surgeon removed the cut suture from the joint with forceps.This added a 30 min delay to the case.The case was completed with no adverse effect to the patient.Additional information requested.Additional information provided 01/22/20: it was reported due to the delay of the case, the patient had to undergo more anesthesia.It was also confirmed that the cut suture was not fully retrieved from the patient.

• Brand Name: SUTURE TENSIONER/CUTTER FOR KNEES
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9693158
• Report Number: 1220246-2020-01650
• Device Sequence Number: 2283788
• Product Code: MDM
• UDI-Device Identifier: 00888867275676
• UDI-Public: 00888867275676
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2020

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: 06/30/2024
• Device Model Number: SUTURE TENSIONER/CUTTER FOR KNEES
• Device Catalogue Number: AR-5815
• Device Lot Number: 912993426
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 04/10/2020
• 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