MAUDE Adverse Event Report: ARTHREX, INC. 1.7MM SUTURETAPE WH/BL W/ CC NEEDLE; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	1.7MM SUTURETAPE WH/BL W/ CC NEEDLE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
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 surgeon feedback was provided indicating that the ar-7511 suturetape disconnects from the needle and sometimes the needle is too aggressive for poor tissue quality.The rep stated the device broke in the patient at the end of the case while the surgeon was pulling the needle through the tissue.It did not alter the case at all, just a minor inconvenience.Associated procedures were completed successfully with no harm.

• Brand Name: 1.7MM SUTURETAPE WH/BL W/ CC NEEDLE
• Common Device Name: SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11724866
• Report Number: 1220246-2021-02947
• Device Sequence Number: 3081164
• Product Code: GAT
• UDI-Device Identifier: 00888867340053
• UDI-Public: 00888867340053
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• 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): 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1.7MM SUTURETAPE WH/BL W/ CC NEEDLE
• Device Catalogue Number: AR-7511
• Device Lot Number: 100011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 04/26/2021
• Patient Sequence Number: 1