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	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 2/28/2023, it was reported by a arthrex employee via (b)(4) that an ar-8704 suturelasso loop was already torn when the surgeon tried to use it.This was discovered during a procedure on (b)(6) 2023 with no patient harm.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint is confirmed.Visual evaluation noted that one side of the closed wire loop suture was broken.The cause remains a use error.Functional testing was not performed due to the damage to the suture wire.

• 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: jared engle ; 8009337001
• MDR Report Key: 19360225
• Report Number: 1220246-2024-03594
• Device Sequence Number: 12354337
• Product Code: LXH
• UDI-Device Identifier: 00888867044760
• UDI-Public: 00888867044760
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 05/21/2024

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: MICRO SUTRLASSO,TFCC,SHT,70°BEND
• Device Catalogue Number: AR-8704
• Device Lot Number: 2129121841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2022
• 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