MAUDE Adverse Event Report: ARTHREX, INC. 1.8MM PERC INSERT KIT FOR FIBERTAK; MANUAL INSTR, GENERAL SURGICAL

Model Number	1.8MM PERC INSERT KIT FOR FIBERTAK
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
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 13-feb-2026, a facility representative reported via (b)(4) that an ar-3610pk-3 fibertak insertion kit drill bit was cold-welding to the drill guide upon the first attempt to drill.It was used to complete the case with no patient affected.

• Brand Name: 1.8MM PERC INSERT KIT FOR FIBERTAK
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 24531849
• Report Number: 1220246-2026-01283
• Device Sequence Number: 9026892
• Product Code: LXH
• UDI-Device Identifier: 00888867358225
• UDI-Public: (01)00888867358225(11)250421(17)300331(10)15423764
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 07/06/2026

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: 1.8MM PERC INSERT KIT FOR FIBERTAK
• Device Catalogue Number: AR-3610PK-3
• Device Lot Number: 15423764
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown