MAUDE Adverse Event Report: Arthrex, Inc. FiberTak RC, DoubLoad Tape BL/W, BLK/W; NON-DEGRADABLE FIXATN FASTENER

Model Number	FiberTak RC, DoubLoad Tape BL/W, BLK/W
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, it was reported by a distributor via an email that for 1 unit of ar-1588tn and 1 unit of ar-3632: the ar-1588tn broke during loop shortening steps on the tendon site while the ar-3632 was pulled out while fixing the all.This was detected during an acl+all reconstruction procedure on (b)(6) 2026.The procedure was completed successfully by using additional ar-1588tn and ar-3632.There was no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: FiberTak RC, DoubLoad Tape BL/W, BLK/W
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50841872
• Report Number: 1220246-2026-04835
• Device Sequence Number: 18707848
• Product Code: MBI
• UDI-Device Identifier: 00888867276901
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K251809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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 RC, DoubLoad Tape BL/W, BLK/W
• Device Catalogue Number: AR-3632
• Device Lot Number: 15535654
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2025
• 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