MAUDE Adverse Event Report: ARTHREX, INC. KL 1.8 FIBERTAK, SHOULDER; NON-DEGRADABLE FIXATN FASTENER

Model Number	KL 1.8 FIBERTAK, SHOULDER
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the labral repair the anchor torn.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.26-november-2025 majung - further information received from arthrex cz: the broken pieces were retrieved from the patient.
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.One unpackaged ar-3636-1 fibertak® (batch 15446327) was received for evaluation.Visual inspection identified that the tip of the inserter was bent.The sutures near the anchor were also frayed/torn.Functional testing could not be performed due to the damage observed on the inserter.The most likely cause of the reported failure is attributed to use-related factors, such as prying or leveraging the device with excessive force.The complaint allegation is confirmed.Refer to the investigation photos.

• Brand Name: KL 1.8 FIBERTAK, SHOULDER
• 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: 23769295
• Report Number: 1220246-2025-05552
• Device Sequence Number: 16100538
• Product Code: MBI
• UDI-Device Identifier: 00888867362857
• UDI-Public: (01)00888867362857(11)250604(17)300531(10)15446327
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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,Followup
• Report Date (Section B): 02/19/2026

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: KL 1.8 FIBERTAK, SHOULDER
• Device Catalogue Number: AR-3636-1
• Device Lot Number: 15446327
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2025
• 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