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

Model Number	DISPOSABLES KIT, FOR FIBERTAK,STRAIGHT
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
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 05/15/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-3600d-3 drill was inserted into the ar-3600d and started drilling, it got stuck in the middle and when tried to force it out, the drill broke.This case was completed by using another product of same product number.No patient harms.
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 interference with the mating instrument and/or prying/leveraging the devices during use.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Visual inspection of the disposables kit for fibertak¿ suture anchor with 1.6 mm drill, straight spear, and obturator revealed that the fibertak was fractured into two pieces.A portion of the tip was found stacked at the distal end of the shaft of the returned mating component, while the remaining section of the shaft exhibited abrasion marks.Functional testing was not performed due to the damage to the device.The most likely cause of the reported failure can be attributed to user error with the device due to misalignment, insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: DISPOSABLES KIT, FOR FIBERTAK,STRAIGHT
• 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: 22144849
• Report Number: 1220246-2025-02380
• Device Sequence Number: 7357187
• Product Code: HWE
• UDI-Device Identifier: 00888867239128
• UDI-Public: 00888867239128
• 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,Followup
• Report Date (Section B): 12/19/2025

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: DISPOSABLES KIT, FOR FIBERTAK,STRAIGHT
• Device Catalogue Number: AR-3600D
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 10/01/2025; 12/17/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 10/09/2025; 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown