MAUDE Adverse Event Report: ARTHREX, INC. DX KNOTLESS FIBERTAK IMPLANT KIT; NON-DEGRADABLE FIXATN FASTENER

Model Number	DX KNOTLESS FIBERTAK IMPLANT KIT
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/03/2025, a sales representative reported via phone that an ar-8991cp dx knotless fibertak implant kits inserter tip popped off.This occurred during a lateral ligament repair on (b)(6) 2025 when the tip of the inserter popped off, the anchor remained in the patient, and the inserter tip was able to be retrieved.There was a delay of about 30 seconds, which did not require additional anesthesia.There was no harm to the patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-8991cp, fibertak®, batch 15371889a, was received for investigation.Visual inspection noted that the shaft was detached from the fibertak® head.Functional testing could not be performed due to the damage to the device.The most likely cause of the detached shaft is attributed to excessive user-applied mechanical forces.The complaint allegation is not confirmed, as the allegation stated that the tip of the inserter was fractured off; however, the returned device had the tip intact.Refer to the attached investigation photos.

• Brand Name: DX KNOTLESS FIBERTAK IMPLANT KIT
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 23300098
• Report Number: 1220246-2025-04607
• Device Sequence Number: 4786973
• Product Code: MBI
• UDI-Device Identifier: 00888867424715
• UDI-Public: (01)00888867424715(11)250325(17)300228(10)15371889A
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K200341
• 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): 12/29/2025

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: DX KNOTLESS FIBERTAK IMPLANT KIT
• Device Catalogue Number: AR-8991CP
• Device Lot Number: 15371889A
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 10/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown