MAUDE Adverse Event Report: ARTHREX, INC. PERC KIT FOR 3.9MM KNOTLESS CORKSCREW; ORTHOPEDIC MANUAL SURG INSTR

Model Number	PERC KIT FOR 3.9MM KNOTLESS CORKSCREW
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/08/2025
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 (b)(6) 2025, it was reported by an arthrex employee via email that for an ar-1941pk, transtendon percutaneous insertion kit compatible with 3.9mm knotless corkscrew®/ knotless fibertak® anchors, the cannulated switching stick was blocked and was unable to be passed over the wire.This was detected during use in a remplissage procedure on (b)(6) 2025.The procedure was completed successfully as a second kit was opened.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the available information, which may include the device (if returned), photographs, videos, event descriptions, and any additional field data, arthrex concludes that the possible cause of the reported failure is user error, specifically related to incorrect user technique or setup error leading to material deformation.The following factors may have contributed to the issue: use of an incorrect insertion angle misalignment during the procedure, potentially causing interference excessive force was applied during use, which may have deformed the switching stick and resulted in blockage the complaint allegation could not be confirmed, as the device was not received for evaluation, and no supporting evidence of the reported failure was provided.

• Brand Name: PERC KIT FOR 3.9MM KNOTLESS CORKSCREW
• 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: 22663080
• Report Number: 1220246-2025-03128
• Device Sequence Number: 20695318
• Product Code: LXH
• UDI-Device Identifier: 00888867351417
• UDI-Public: (01)00888867351417(11)250109(17)291231(10)15371053
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2025

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: PERC KIT FOR 3.9MM KNOTLESS CORKSCREW
• Device Catalogue Number: AR-1941PK
• Device Lot Number: 15371053
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown