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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
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 (b)(6) 2025, it was reported by a sales representative via email that an ar-3670 fibertak biceps implant system failed during a procedure.No additional information was provided.Additional information requested on 5/13/2025.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.
Event or Problem Description
Additional information received on 5/15/2025: this was discovered while the fibertak was in the patient during an mcl reconstruction procedure on (b)(6) 2025.The anchor was removed, and no fragments remained inside the patient.The case was completed using an ar-3633sp self-punching fibertak.The case experienced a brief delay of a few minutes but proceeded without the need for additional anesthesia.
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 of the device due to improper bone preparation and/or prying/leveraging during use.

• 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: 22019570
• Report Number: 1220246-2025-02043
• Device Sequence Number: 15823581
• Product Code: MBI
• UDI-Device Identifier: 00888867305427
• UDI-Public: (01)00888867305427(11)230517(17)280430(10)15093837
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181769
• 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,Followup
• Report Date (Section B): 10/08/2025

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: FIBERTAK BICEPS IMPLANT SET
• Device Catalogue Number: AR-3670
• Device Lot Number: 15093837
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 05/15/2025; 10/02/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 06/09/2025; 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown