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 Codes	Positioning Failure (1158); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 one unpackaged ar-3636-1 fibertak batch 15555549 was received for investigation.Visual evaluation revealed that the implant appeared to be removed and the sutures were cut.Functional testing could not be performed sue to the damage to the device.The quality of the bone was not provided.The most likely cause for the reported failure can be attributed to a patient-specific factor associated with bone quality, bone density, or local bone conditions.Resulting in inadequate implant fixation within the prepared bone site, leading to implant instability.The allegation of implant instability could not be 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 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50018659
• Report Number: 1220246-2026-04026
• Device Sequence Number: 21483682
• Product Code: MBI
• UDI-Device Identifier: 00888867362857
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K260561
• 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): 09/09/2026

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: 15555549
• 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: 07/07/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2026
• 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