MAUDE Adverse Event Report: ARTHREX, INC. DOUBLE LOADED KNOTLESS FIBERTAK, KNEE; NON-DEGRADABLE FIXATN FASTENER

Model Number	DOUBLE LOADED KNOTLESS FIBERTAK, KNEE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/09/2025
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 14-jan-2026, a monthly maude database review identified a report involving an ar-3740sp knee double loaded knotless fibertak anchor that had not been previously reported to arthrex.According to the maude narrative, during surgery, the surgeon inserted the self-punching anchor using the inserter.Upon removal of the inserter from the knee, the tip was noted to be missing.Radiographs identified a small fragment of the inserter, approximately 1¿2 mm in size, retained in the patient.The surgeon explained that attempting to retrieve the retained foreign body could cause additional damage and therefore recommended leaving it in place, as it is not expected to harm the patient.Additional information was received on 29-jan-2026: this was discovered during a left knee revision anterior cruciate ligament reconstruction and lateral extra-articular tenodesis.The fibertak anchor was successfully implanted, and no surgical delays were reported.The procedure was performed under general anesthesia with the addition of a nerve block.Additional information was received on 5-feb-2026: according to the facility representative, the ar-3740sp knee double loaded knotless fibertak anchor broke during the revision surgery.No information regarding the initial surgery was provided at this time.The revision procedure was performed due to a motorcycle accident.At this time, it is unknown whether any arthrex products were used during the initial surgery or if any were removed during the revision procedure.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event description, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause is attributed to user error, including excessive force applied and failure to insert the anchor in the same orientation as the prepared bone hole.Refer to dfu-0054-eo revision 8 bio-fastak, fastak, suturetak and fibertak suture anchors g.Precautions 5.Insert the anchor with the same orientation as that of the prepared drilled bone hole to avoid damage to the anchor or inserter.6.Suturetak and fibertak suture anchors only: anchors loaded on flexible drivers: the drill guide tip must remain in contact with the bone surface during the drilling and implant impaction steps of the procedure.Failure to do so may result in difficulty seating the implant to its intended depth.Avoid excessive impaction during anchor insertion as this could lead to inserter damage and/or breakage.If insertion resistance is encountered, do not impact harder.Replace the implant and repeat the drilling/insertion process.8.Self-punching suture anchors only: insertion in very hard bone may require pre-punching a bone socket to avoid damage to the implant.9.Self-punching suture anchors only: ensure that the angle of anchor insertion is perpendicular to the bone.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: DOUBLE LOADED KNOTLESS FIBERTAK, KNEE
• 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: 24304494
• Report Number: 1220246-2026-00494
• Device Sequence Number: 5315186
• Product Code: MBI
• UDI-Device Identifier: 00888867428041
• UDI-Public: (01)00888867428041(11)250909(17)300831(10)15495382
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K251809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2026

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: DOUBLE LOADED KNOTLESS FIBERTAK, KNEE
• Device Catalogue Number: AR-3740SP
• Device Lot Number: 15495382
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2025
• 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