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

Model Number	FIBERTAK
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 22nd july 2025, it was reported by a distributor via email that for 2 units of ar-3638, knotless fibertak¿ with #2 suture (5-box), the knotless fibertak passing suture was broken during suture passing process causing the fixation suture to not be able to pass through the anchor and complete the tensionable mechanism.Both anchors had the same issue.This was detected during use in a slap procedure on (b)(6) 2025.The procedure was completed successfully as a new fibertak was used.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 the complaint allegation was not confirmed.The returned device is not evidence of the failure.One unpackaged ar-3638 batch 15352087 was received for evaluation.Visual evaluation of the returned inserter found no damage.Functional testing was not performed because the suture system was not returned.No problem found.

• Brand Name: FIBERTAK
• 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: 22750291
• Report Number: 1220246-2025-03360
• Device Sequence Number: 9547353
• Product Code: MBI
• UDI-Device Identifier: 00888867292123
• UDI-Public: (01)00888867292123(11)241122(17)291031(10)15352087
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K130458
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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
• Device Catalogue Number: AR-3638
• Device Lot Number: 15352087
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown