MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK BICEPS IMPLANT SET; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERTAK BICEPS IMPLANT SET
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/01/2025
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 07-jan-2026, an fda medsun notification was received via email.A facility representative reported that during a left knee diagnostic arthroscopy with open posterior cruciate ligament repair and medial collateral ligament repair and reconstruction using semitendinosus autograft, a small fragment, approximately a 1 mm tine from the inserter of an ar-3670 fibertak biceps implant system, broke off within the surgical site during passage.The fragment was not retrieved and was left in the patient due to its size and inability to be detected under fluoroscopy.The surgeon determined that retrieval posed more risk than benefit and expressed no concerns regarding patient impact.Additional information was received on 13-jan-2026: this event occurred on 01-dec-2025.The case was completed using three arthrex double-loaded 1.8 mm soft suturetak anchors, which remained stable after implantation.There was no case delay, and no additional anesthesia was administered to the patient.
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 due to misaligned insertion and/or improper bone preparation.

• Brand Name: FIBERTAK BICEPS IMPLANT SET
• 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: 24146332
• Report Number: 1220246-2026-00278
• Device Sequence Number: 15675259
• Product Code: MBI
• UDI-Device Identifier: 00888867305427
• UDI-Public: (01)00888867305427(11)250903(17)300831(10)15492467
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K251809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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: FIBERTAK BICEPS IMPLANT SET
• Device Catalogue Number: AR-3670
• Device Lot Number: 15492467
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2025
• 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 Age: 20 YR
• Patient Sex: Male