MAUDE Adverse Event Report: ARTHREX, INC. NDL,SUTRING,NIT W/WIRE LOOP END; MANUAL INSTR, GENERAL SURGICAL

Model Number	NDL,SUTRING,NIT W/WIRE LOOP END
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a cruciate ligament surgery the devices tore out.Per complaint reporter there was no harm for patient, operator or third party.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.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-1291s nitinol suturing needles with wire loop end, serial/batch (b)(6), was received for investigation.Two devices, line 1 and line 2, were received together without distinction.Both devices will be evaluated as possible line 1 and line 2.Visual evaluation of the device found that the nitinol needle was bent on both ends, and the loop swage was detached from the devices.Functional testing could not be performed due to the device's damage.The most likely cause of the reported and observed damage is user error, specifically applying excessive force during use.
Event or Problem Description
Update dw 03-mar-2025: further information was provided that the wire tore during the procedure.

• Brand Name: NDL,SUTRING,NIT W/WIRE LOOP END
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 21324868
• Report Number: 1220246-2025-00281
• Device Sequence Number: 7865646
• Product Code: MDM
• UDI-Device Identifier: 00888867007109
• UDI-Public: (01)00888867007109(11)240604(17)290531(10)15258419
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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: NDL,SUTRING,NIT W/WIRE LOOP END
• Device Catalogue Number: AR-1291S
• Device Lot Number: 15258419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown