MAUDE Adverse Event Report: ARTHREX, INC. DBL LOADED KNEE FIBERTAK, W/ NEEDLES; NON-DEGRADABLE FIXATN FASTENER

Model Number	DBL LOADED KNEE FIBERTAK, W/ NEEDLES
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/08/2025
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 12/08/2025, a sales representative reported via phone that an ar-3730sp double loaded knee fibertak® anchor experienced a failure when one of the fork tips broke off during an open shoulder procedure.The patient had average bone quality, which had been prepared using a drill.The fragment was not retrieved.There was no delay in the procedure, and the implant was successfully placed.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on photographic evidence of an ar-3730sp, batch 15460270, that displays the tip of the device is broken.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 improper bone prep; misaligned insertion; prying/leveraging the device during insertion.Per the directions for use (dfu) dfu-0054-eo bio-fastak, fastak¿, suturetak® and fibertak® suture anchors; e.Warnings: 7.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.Visually inspect all devices immediately after use for the potential of loose body remnants left behind in the patient.9.Suturetak and fibertak suture anchors only: drilling in very hard bone may require cycling the drill while maintaining consistent alignment of the drill guide.Increased size, hard bone drills are also available for use.

• Brand Name: DBL LOADED KNEE FIBERTAK, W/ NEEDLES
• 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: 23906940
• Report Number: 1220246-2025-05861
• Device Sequence Number: 21119187
• Product Code: MBI
• UDI-Device Identifier: 00888867431645
• UDI-Public: (01)00888867431645(11)250702(17)300630(10)15460270
• 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: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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: DBL LOADED KNEE FIBERTAK, W/ NEEDLES
• Device Catalogue Number: AR-3730SP
• Device Lot Number: 15460270
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown