MAUDE Adverse Event Report: ARTHREX, INC. 4-0 FW,18" W/TPR NDL 12.3 MM; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	4-0 FW,18" W/TPR NDL 12.3 MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that with the reported device the needle came off the suture.There was no harm or adverse event for patient, operator or third party reported.No further information received.(b)(6) 2021 update: it was confirmed that during an arthroscopy surgery with three devices ar-7230-01 (lot 23869) the needle broke off the suture inside the patient.According to the description from the customer the needles stuck in the patient and when the sutures were tightened, the suture tore from the needle.Subsequently the needles were removed from the patient.No harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: 4-0 FW,18" W/TPR NDL 12.3 MM
• Common Device Name: SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12392680
• Report Number: 1220246-2021-03577
• Device Sequence Number: 4181494
• Product Code: GAT
• UDI-Device Identifier: 00888867041615
• UDI-Public: 00888867041615
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122374
• 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
• Report Date (Section B): 08/31/2021

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 Expiration Date: 10/31/2025
• Device Model Number: 4-0 FW,18" W/TPR NDL 12.3 MM
• Device Catalogue Number: AR-7230-01
• Device Lot Number: 23869
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 08/31/2021
• Patient Sequence Number: 1