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

Model Number	FIBERTAK BICEPS IMPLANT SET
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
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 04/15/2025, a sales representative reported via email that an ar-3670 fibertak biceps implant system had the drill bound up and did not fit down the guide well when drilling.As shown in the photo through the slotted drill guide, the plastic has become stuck and has even begun to melt due to friction.The patient was not harmed.This was discovered during a procedure on (b)(6) 2025.Additional information was requested.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.The complaint allegation is confirmed.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 misaligned insertion and/or prying and leveraging the device during insertion.
Event or Problem Description
Additional information was received on 05/12/2025: a biceps tenodesis procedure was performed on (b)(6) 2025, utilizing the ar-3670 fibertak biceps implant system to complete the case.The procedure experienced a brief delay of approximately two minutes, but no additional anesthesia was required.Binding occurred immediately during the insertion.The melting plastic affected the integrity of the guide, and advancing the drill required excessive force.The bone socket was prepared using the guide from the surgical kit, and the patient¿s bone quality was assessed as good.No pieces of the instrument or implant broke, and no additional debris was produced.No adverse effects or significant damage were reported for the patient following surgery.

• 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: 22001793
• Report Number: 1220246-2025-01989
• Device Sequence Number: 7109467
• Product Code: MBI
• UDI-Device Identifier: 00888867305427
• UDI-Public: (01)00888867305427(11)250115(17)291231(10)15373515
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 10/10/2025

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: 15373515
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown