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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
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 05-feb-2026, a sales representative reported via (b)(4) that the ar-1941pk perc kit for 3.9mm knotless corkscrew had a bent dilator out of the package and would not slide with the guide due to the difficulty of sliding the guide over the top of the dilator the surgeon needed to use a smaller switching stick to move forward with the case.This issue was discovered during a case with no patient harm.

• 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: 24428701
• Report Number: 1220246-2026-00880
• Device Sequence Number: 13360332
• Product Code: LXH
• UDI-Device Identifier: 00888867351417
• UDI-Public: (01)00888867351417(11)250915(17)300831(10)15498226
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 06/22/2026

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: 15498226
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2025
• 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