MAUDE Adverse Event Report: ARTHREX, INC. HYBRID FIBERTAK WITH NEEDLES, KNEE; NON-DEGRADABLE FIXATN FASTENER

Model Number	HYBRID FIBERTAK WITH NEEDLES, KNEE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
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 10/22/2025, a distributor reported via email an issue involving the ar-3770sp hybrid knee fibertak anchor during an mpfl reconstruction procedure performed on (b)(6) 2025.The anchor was implanted in the patella.The implant was initially secure, and the graft was positioned within the blue loop.However, while the graft was inserted into the femur, one strand of the blue loop broke.The breakage appeared to occur at one extremity of the loop.Additionally, the surgeon noted that the blue loop of a second implant used during the same procedure seemed loose.Additional information has been requested on 10/29/2025.
Event or Problem Description
Additional information was received on 11/3/2025: the second implant with the loose blue loop was also an ar-3770sp hybrid knee fibertak from the same lot number.It was reported that the blue loop broke and remained inside the patient along with the anchor.Only the black sutures were removed; the end of the implant itself stayed in the patient.The case was completed using product part number ar-2324kbcc biocomposite knotless swivelock.The surgery was delayed by approximately 30 minutes while the issue was investigated and determined to be related to the fibertak.No additional anesthesia was administered to the patient.No adverse patient effects have been reported during or following the procedure due to this issue.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
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 user-applied excessive mechanical forces, such as over-tensioning.

• Brand Name: HYBRID FIBERTAK WITH NEEDLES, 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: 23427728
• Report Number: 1220246-2025-04909
• Device Sequence Number: 8179100
• Product Code: MBI
• UDI-Device Identifier: 00888867428065
• UDI-Public: (01)00888867428065(11)250620(17)300531(10)15454127
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K251809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2026

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: HYBRID FIBERTAK WITH NEEDLES, KNEE
• Device Catalogue Number: AR-3770SP
• Device Lot Number: 15454127
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: Not provided; 03/02/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 11/11/2025; 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown