MAUDE Adverse Event Report: ARTHREX, INC. MICRO SUTRLASSO,TFCC,SHT,70°BEND; ORTHOPEDIC MANUAL SURG INSTR

Model Number	MICRO SUTRLASSO,TFCC,SHT,70°BEND
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 01/30/2024, it was reported by a sales representative that the lasso loop within an ar-8704 micro sutrlasso,tfcc,sht,70°bend was unable to advance during a arthrobrostrom surgery performed by dr.Anandakumar.The case was resolved by using a 14g cannula as a replacement to ar-8704.There was no patient harm.
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
Additional information: g3, h3, h6.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex concluded that the most likely cause.The most likely cause of the reported failure is user error following the device's surgical technique.The complaint allegation was not confirmed.The device was not received for evaluation, and the received photograph does not provide evidence of the failure.

• Brand Name: MICRO SUTRLASSO,TFCC,SHT,70°BEND
• 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: 18714351
• Report Number: 1220246-2024-00994
• Device Sequence Number: 3703430
• Product Code: LXH
• UDI-Device Identifier: 00888867044760
• UDI-Public: 00888867044760
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 05/12/2025

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 Expiration Date: 05/31/2026
• Device Model Number: MICRO SUTRLASSO,TFCC,SHT,70°BEND
• Device Catalogue Number: AR-8704
• Device Lot Number: 1165113187
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2024
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• 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