MAUDE Adverse Event Report: ARTHREX, INC. SP 2.6 MM KNOTLESS FIBERTAK ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	SP 2.6 MM KNOTLESS FIBERTAK ANCHOR
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/21/2025
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 10/21/2025, a sales representative reported via email that two ar-3641sp self-punching knotless 2.6 fibertak anchor with #5suture failed due to a malfunction in the knotless mechanism.The anchors did not pass sufficiently during use.All broken pieces were successfully removed from the patient; however, the anchors remain in the humeral head.The procedure was completed using an ar-3632sp fibertak sp suture anchor.This was discovered during a remplissage procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested on 10/27/2025.
Event or Problem Description
Additional information was received on 10/29/2025: this was an arthroscopic procedure.The issue occurred during engagement of the locking mechanism.The anchors were successfully inserted into the humeral head prior to the malfunction.The surgery was delayed by approximately 30 to 45 minutes.Additional anesthesia was administered to the patient, although the exact duration is unknown.Adverse patient effects have not been confirmed yet, but a revision remplissage procedure may be required.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.The complaint device was not received for evaluation.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 the most likely cause.The most likely cause of the reported failure is user error, including incorrect surgical technique during device application.These factors may have contributed to the malfunction or compromised the integrity of the implant during the procedure.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• Brand Name: SP 2.6 MM KNOTLESS FIBERTAK ANCHOR
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: 23425418
• Report Number: 1220246-2025-04892
• Device Sequence Number: 18548270
• Product Code: MBI
• UDI-Device Identifier: 00888867341906
• UDI-Public: (01)00888867341906(11)250225(17)300131(10)15395329
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K251809
• 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): 11/18/2025

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: SP 2.6 MM KNOTLESS FIBERTAK ANCHOR
• Device Catalogue Number: AR-3641SP
• Device Lot Number: 15395329
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• 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