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

Model Number	TIGHT CURVED SPEAR, FIBERTAK, REUSABLE
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
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 01/27/2025, it was reported by a arthrex subsidiary employee via (b)(6) that an ar-3610ctc-2 fibnertak spear and an ar-3600 fibertak anchor became stuck in the drill guide when the surgeon went to insert.This occurred during use in an arcr case with no patient harm.This case was completed by using another product of same product number.
Additional Manufacturer Narrative
Additional information: 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 for the reported failure can be attributed to user error of the device due to misaligned insertion and/or prying/leveraging the device during use.

• Brand Name: TIGHT CURVED SPEAR, 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: 21436540
• Report Number: 1220246-2025-00599
• Device Sequence Number: 19961430
• Product Code: LXH
• UDI-Device Identifier: 00888867354296
• UDI-Public: (01)00888867354296(11)230918(10)0072329
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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: TIGHT CURVED SPEAR, FIBERTAK, REUSABLE
• Device Catalogue Number: AR-3610CTC-2
• Device Lot Number: 0072329
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2023
• 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