MAUDE Adverse Event Report: ARTHREX, INC. SUTURELASSO, 90 DEGREE STRAIGHT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SUTURELASSO, 90 DEGREE STRAIGHT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
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 04/30/2025, it was reported by a sales representative via (b)(4) that an ar-4068-90 suture lasso tip of it broke off in the patient.The surgeon was able to visualize the piece and remove it.This occurred during use in a case with no patient effect.Per facility: "to further confirm a post-op x-ray was performed and found to be negative for any metallic foreign body." "there is soft tissue swelling and bubbles of soft tissue gas around the right shoulder and in the supraclavicular region.No metallic foreign body is seen.Bony alignment is normal.The joint spaces are maintained." "soft tissue gas, presumably postoperative.".
Additional Manufacturer Narrative
Complaint allegation is confirmed.Upon visual inspection, it was noted that both tips of the bone reduction forceps, curved, pointed had bent.Laser markings were rusted and faded.Functional testing was not performed due to the damage to the device.The most likely cause of the reported failure can be attributed to user-applied excessive mechanical forces.

• Brand Name: SUTURELASSO, 90 DEGREE STRAIGHT
• 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: 22095244
• Report Number: 1220246-2025-02237
• Device Sequence Number: 20566833
• Product Code: LXH
• UDI-Device Identifier: 00888867031517
• UDI-Public: 00888867031517
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 07/18/2025

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, 90 DEGREE STRAIGHT
• Device Catalogue Number: AR-4068-90
• Device Lot Number: 4312154361
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown