MAUDE Adverse Event Report: ARTHREX, INC. DISPOSABLE KIT, KNOTLESS SUTURETAK OPEN; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	DISPOSABLE KIT, KNOTLESS SUTURETAK OPEN
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported on 01/10/2023 by a sales representative via sems that an ar-1938dss disposables kit drill sleeve cold welded and started flaking off during procedure.Case involvement, device broke during use.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 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(s) for the observed and reported failure is a user error, misaligned insertion, or excessive force by leveraging/prying the device.

• Brand Name: DISPOSABLE KIT, KNOTLESS SUTURETAK OPEN
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16263404
• Report Number: 1220246-2023-06179
• Device Sequence Number: 7388889
• Product Code: MDM
• UDI-Device Identifier: 00888867287389
• UDI-Public: 00888867287389
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/20/2024

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 Expiration Date: 02/28/2026
• Device Model Number: DISPOSABLE KIT, KNOTLESS SUTURETAK OPEN
• Device Catalogue Number: AR-1938DSS
• Device Lot Number: 12824023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown