MAUDE Adverse Event Report: ARTHREX, INC. SUTURELASSO 25° LEFT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SUTURELASSO 25° LEFT
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a ramp lesion surgery a device was opened and it was impossible to get the pds 0 suture up into the hook.The same thing was tried with pds 1, but the suture jammed in the knurls and wouldn't come out at the end of the hook.This was tried again with 2 other hooks but the surgeon had the same problem.All 3 devices ar-6068-25l were from the same batch 3030128765.Another hook with the ref.((b)(4).) was required to be able to suture the meniscus.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device (4068-25tlf).It was not necessary to switch the surgical technique or do a second surgery.
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.
Additional Manufacturer Narrative
The complaint was confirmed.Three unpackaged ar-6068-25l serial/batch number (b)(6) were received for investigation.All three devices arrived without suture.The returned devices were visually inspected, and it was noted: device# 1 the tip shows contamination and nicks.Device#2 nicks around the tip hole.Device#3 nicks round the tip hole.Functional test of the wheels on the three devices did not find resistance.The wheels move forward and backward without resistance.However, a functional test with a suture-passing wire found that the wire did not advance when the wheels moved.This is the third occurrence with the same part/batch number.The most likely cause for the reported failure is a supplier process.

• Brand Name: SUTURELASSO 25° LEFT
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: emily shafer ; 8009337001
• MDR Report Key: 17442597
• Report Number: 1220246-2023-07395
• Device Sequence Number: 19465610
• Product Code: GAT
• UDI-Device Identifier: 00888867247505
• UDI-Public: 00888867247505
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K122374
• 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): 10/18/2023

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: SUTURELASSO 25° LEFT
• Device Catalogue Number: AR-6068-25L
• Device Lot Number: 3030128765
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2023
• Supplement Date Received by Manufacturer: 07/03/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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