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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
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
It was reported that during a rotator cuff repair surgery the anchor pulled out of the pre-drilled hole.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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.-one unpackaged ar-3636-1, fibertak®, batch 15316902, was received for evaluation.-upon visual inspection, it was noted that the inplant was bunched and the sutures were cut.- functional testing could not be performed due to the damage to the device.-the most likely cause for the reported failure can be attributed to misuse due to improper bone preparation, misaligned insertion, or prying/leveraging the device during insertion -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: 22839510
• Report Number: 1220246-2025-03531
• Device Sequence Number: 4823037
• Product Code: MBI
• UDI-Device Identifier: 00888867362857
• UDI-Public: (01)00888867362857(11)240913(17)290831(10)15316902
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K221396
• 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): 10/10/2025

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: KL 1.8 FIBERTAK, SHOULDER
• Device Catalogue Number: AR-3636-1
• Device Lot Number: 15316902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown