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

Model Number	FIBERTAK BICEPS IMPLANT SET
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
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 09/27/2024, it was reported by a sales representative via phone that an ar-3670 fibertak biceps implant system had the drill got caught on the slit of the drill guide.Nothing broke inside the patient, and debris was produced only on the outside of the patient.Another ar-3670 fibertak biceps implant was used from a different lot with no issues.There was no case delay.This was discovered during a biceps tenodesis procedure on (b)(6) 2024, with no reported patient harm.
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 misaligned insertion and/or prying/leveraging the device 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: 20359466
• Report Number: 1220246-2024-07982
• Device Sequence Number: 12562734
• Product Code: MBI
• UDI-Device Identifier: 00888867305427
• UDI-Public: (01)00888867305427(11)240722(17)290630(10)15290743
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

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: 15290743
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2024
• 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