MAUDE Adverse Event Report: ARTHREX, INC. DISPOSABLES KIT, FOR DX FIBERTAK; POWERED SURG ORTHOPEDIC INSTR

Model Number	DISPOSABLES KIT, FOR DX FIBERTAK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint allegation is confirmed.Visual inspection identified that the dx fibertak drill guide had stuck the mating part ar-8990st without the soft anchor/suture tape.Functional testing was not performed due to the damage to the device.The method of bone preparation and the quality of the bone encountered were not specified.The most likely cause of the reported failure can be attributed to user error with the device due to misaligned insertion, and/or prying/leveraging during insertion.
Event or Problem Description
On 24-apr-2026, an arthrex subsidiary employee returned an ar-8990st fibertak dx suture anchor that broke during insertion into the bone.Additionally, ar-8990ds disposable kit for dx fibertak returned because the 2 components were stuck together and could not be disassembled.The tip of the device's guidewire was bent.There was no significant case delay, no additional anesthesia administered, and no patient harm reported.

• Brand Name: DISPOSABLES KIT, FOR DX FIBERTAK
• Common Device Name: POWERED SURG ORTHOPEDIC 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: 25187343
• Report Number: 1220246-2026-02884
• Device Sequence Number: 10384769
• Product Code: HWE
• UDI-Device Identifier: 00888867264984
• UDI-Public: 00888867264984
• 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
• Report Date (Section B): 05/15/2026

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: DISPOSABLES KIT, FOR DX FIBERTAK
• Device Catalogue Number: AR-8990DS
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/24/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown