MAUDE Adverse Event Report: ARTHREX, INC. REELPASS SUTR LASSO,45° CRV RT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	REELPASS SUTR LASSO,45° CRV RT
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2023
Type of Reportable Event	Malfunction
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.Per (b)(4).Rev.24.0, product history reviews are required for all complaints classified as an early warning or adverse event and any complaint where investigation reveals a confirmed cause category of design, process, product, or supplier.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user error due to user-applied excessive mechanical forces.As no further investigation was able to be performed no change in harm was identified.This complaint will be included in trending per (b)(4).
Event or Problem Description
It was reported on 02/14/2023 by a sales representative via sems that an ar-6069-45l and ar-6069-45r suture lasso would not unspool the passing suture.Case involvement, no patient effect.

• Brand Name: REELPASS SUTR LASSO,45° CRV RT
• 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: 19458400
• Report Number: 1220246-2024-04823
• Device Sequence Number: 17845537
• Product Code: LXH
• UDI-Device Identifier: 00888867115873
• UDI-Public: 00888867115873
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2024

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: REELPASS SUTR LASSO,45° CRV RT
• Device Catalogue Number: AR-6069-45R
• Device Lot Number: 15037915
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2022
• 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