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

Model Number	STRAIGHT SPEAR, FM, FIBERTAK, REUSABLE
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/06/2025
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 05/06/2025, a sales representative reported via (b)(4) that an ar-3610f straight fibertak® spear drill bit got completely stuck inside the guide and was unusable.This occurred during use.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 complaint allegation is confirmed.-upon visual inspection, inside the straight fibertak® spear, fishmouth, reusable, a drill is stuck and bent.-functional testing was not performed due to the damage to the device.The most likely cause of the reported failure is user error, such as applying excessive mechanical forces, misaligned insertion, and/or prying/leveraging the device during use.

• Brand Name: STRAIGHT SPEAR, FM, 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: 22237160
• Report Number: 1220246-2025-02492
• Device Sequence Number: 8018931
• Product Code: LXH
• UDI-Device Identifier: 00888867354272
• UDI-Public: 00888867354272
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 09/19/2025

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: STRAIGHT SPEAR, FM, FIBERTAK, REUSABLE
• Device Catalogue Number: AR-3610F
• Device Lot Number: 0072434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 05/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown