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	02/13/2025
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 2/13/2025, a sales representative reported via phone that an ar-3670 fibertak biceps implant system had an issue.During a subpectoral biceps tenodesis procedure on (b)(6) 2025, when the surgeon was using the drill guide, he stated that at the very distal tip of the drill guide, it felt like a very snug fit and that the drill seemed too big for the drill guide.When trying to drill inside the patient, the drill got stuck inside the drill guide.Both devices were stuck together and removed from the patient in one piece.Nothing broke inside the patient, no debris was produced, and there was no harm to the patient.The complaint devices were discarded.Another ar-3671ds fibertak biceps disposables kit with an unknown lot number was opened and used with the fibertak double-loaded anchor from the ar-3670 fibertak biceps implant system to complete the procedure successfully.There was a 3-minute case delay reported, and no additional anesthesia was administered.This occurred during use with no reported patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed.Photographic evidence provided from the field of an unpackaged ar-3670, with batch number 15348991, revealed that there was a drill stuck inside the guide.Additionally, the tip appears to be damaged.Therefore, arthrex was able to deduce the cause of the complaint misuse due to prying and leveraging the device with excess force 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: 21468958
• Report Number: 1220246-2025-00676
• Device Sequence Number: 14365702
• Product Code: MBI
• UDI-Device Identifier: 00888867305427
• UDI-Public: (01)00888867305427(11)241118(17)291031(10)15348991
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/10/2025

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: 15348991
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• 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