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	07/17/2025
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 surgey the anchor dislodged out of the predrilled 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 damaged.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.

• 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: 22736993
• Report Number: 1220246-2025-03304
• Device Sequence Number: 9103920
• Product Code: MBI
• UDI-Device Identifier: 00888867362857
• UDI-Public: (01)00888867362857(11)250206(17)300131(10)15384961
• 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): 10/13/2025

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: 15384961
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown