MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK SUTURE ANCHOR; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERTAK SUTURE ANCHOR
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
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 labrum stabilization surgery the anchors ar-3600 (lot: 15232907 & 15246457) did not fit through the drill sleeve ar-3610ctc.According to the surgeon no harm for patient, operator or third party occurred.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.Complaint allegation is not confirmed.Upon visual inspection, the packaging material was noted to be unopened.No device from the box was used; the five components inside were sealed.However, the device that was used, which did not fit through the drill sleeve of the ar-3610ctc, was not returned for investigation to replicate the issue reported.Functional testing was performed with mating part ar-3610ctc, and part did not get stuck in the drill.No problem found.

• Brand Name: FIBERTAK SUTURE ANCHOR
• 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: 20415806
• Report Number: 1220246-2024-08060
• Device Sequence Number: 8613005
• Product Code: MBI
• UDI-Device Identifier: 00888867101890
• UDI-Public: (01)00888867101890(11)240510(17)290430(10)15246457
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K181769
• 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): 03/07/2025

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: FIBERTAK SUTURE ANCHOR
• Device Catalogue Number: AR-3600
• Device Lot Number: 15246457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2024
• 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