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 Codes	Positioning Failure (1158); Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/03/2025
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 3/31/2025, it was reported by a sales representative via email that an ar-3770sp hybrid knee fibertak anchor was not loaded correctly and, as a result, did not function.There was no impact on the case or the patient.This was discovered during a procedure on (b)(6) 2025.Additional information requested on 4/24/2025.
Additional Manufacturer Narrative
Additional information: b5, 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 the most likely cause.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.The allegation that this was an out-of-box occurrence can't be verified, as the device was not returned for evaluation.Additionally, no photographic evidence was submitted.
Event or Problem Description
The case was completed using another ar-3770sp hybrid knee fibertak anchor without further impacting the procedure.There was no delay, additional anesthesia, or fragments reported.No further details were available or provided regarding the event.

• 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: 21917133
• Report Number: 1220246-2025-01762
• Device Sequence Number: 8907524
• Product Code: MBI
• UDI-Device Identifier: 00888867428065
• UDI-Public: (01)00888867428065(11)241001(17)290930(10)15324933
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K232973
• 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): 08/06/2025

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: HYBRID FIBERTAK WITH NEEDLES, KNEE
• Device Catalogue Number: AR-3770SP
• Device Lot Number: 15324933
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2024
• 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