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

Model Number	FIBERTAK DISPOSABLES STRAIGHT KIT
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
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 03/07/2025, a sales representative via (b)(4) reported that (qty.2) of an ar-3638ds knotless fibertak disposable kit had the drill get stuck or cold welded in the drill guide when they went to drill and would not advance down the guide or would not come out.The drill ended up breaking in the guide.They opened a new kit, and the same thing happened.The drill was getting stuck down the guide.They could remove the drill from the guide, but it would not go all the way down to the positive stop.They noticed that towards the start of the drill flutes, where the lot number is on the drill bit, it seems like it¿s starting to rub at that spot and is taking off the numbers.The case was completed successfully.No reported pieces were breaking off inside the patient.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint allegation is confirmed by the attached picture, which shows the tip's drill broken off and stacked inside the shaft.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 misalignment, prying/leveraging, and/or excessive force used during insertion.

• Brand Name: FIBERTAK DISPOSABLES STRAIGHT KIT
• 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: 21664376
• Report Number: 1220246-2025-01115
• Device Sequence Number: 7713686
• Product Code: LXH
• UDI-Device Identifier: 00888867287440
• UDI-Public: (01)00888867287440(11)241011(17)290930(10)15330353
• 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): 09/05/2025

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: FIBERTAK DISPOSABLES STRAIGHT KIT
• Device Catalogue Number: AR-3638DS
• Device Lot Number: 15330353
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2024
• 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