MAUDE Adverse Event Report: ARTHREX, INC. STRAIGHT SPEAR, CT, FIBERTAK, REUSABLE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	STRAIGHT SPEAR, CT, FIBERTAK, REUSABLE
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
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 15-dec-2025, it was reported by a sales representative via (b)(4) that an ar-3610ct straight spear fibertak drill bit was bound up, stuck and would not come out.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 one unpackaged ar-3610ct straight spear ct fibertak, batch 0072437, was received for investigation.Visual inspection revealed a broken drill inside the device, with the drill tip bent.Functional testing could not be performed due to the extent of the device's damage.The observed damage is most consistent with use-related factors, such as misaligned insertion and/or prying or leveraging of the drill during use, resulting in bending and fracture.Based on the physical evidence observed, the complaint allegation is confirmed.Refer to the attached investigation photographs.

• Brand Name: STRAIGHT SPEAR, CT, FIBERTAK, REUSABLE
• 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: 23956948
• Report Number: 1220246-2026-00035
• Device Sequence Number: 5625898
• Product Code: LXH
• UDI-Device Identifier: 00888867354258
• UDI-Public: (01)00888867354258(11)250120(10)0072437
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 02/13/2026

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: STRAIGHT SPEAR, CT, FIBERTAK, REUSABLE
• Device Catalogue Number: AR-3610CT
• Device Lot Number: 0072437
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown