MAUDE Adverse Event Report: ARTHREX, INC. SUTURELASSO SD WIRE LOOP; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SUTURELASSO SD WIRE LOOP
Medical Device Problem Codes	Material Fragmentation (1261); Peeled/Delaminated (1454)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
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
On 17th june 2025, it was reported by an arthrex's employee via email that for an ar-4068-05sd, suturelasso¿ sd wire loop, the wire coating peeled off wile relaying after suture passing.There was a delay of about 20 minutes in removing the peeling coating from the patient's body.This was detected during an arthro brostrom surgery on (b)(6) 2025.The case was completed successfully by using a replacement product of ar-4068-05sd.There was no patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is confirmed by the attached picture, which shows some flashes on the glove which came from the coating, per the customer.No picture of the suturelasso was provided.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error in using the device due to applying excessive mechanical forces during suture passing and/or excessively opening the loop.

• Brand Name: SUTURELASSO SD WIRE LOOP
• 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: jared engle ; 8009337001
• MDR Report Key: 22463321
• Report Number: 1220246-2025-02822
• Device Sequence Number: 8551000
• Product Code: LXH
• UDI-Device Identifier: 00888867031418
• UDI-Public: (01)00888867031418(11)240701(17)290630(10)4170150246
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 10/02/2025

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: SUTURELASSO SD WIRE LOOP
• Device Catalogue Number: AR-4068-05SD
• Device Lot Number: 4170150246
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 10/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown