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

Model Number	FIBERTAK SUTURE ANCHOR
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
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 surgery the implant was incompatible with the instrument and therefore not possible to use.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.Complaint allegation is not confirmed.One unpackaged ar-3600-1 fibertak was received for investigation.Visual evaluation of the returned device noted the device was returned fully assembled with no apparent issues.Functional testing was performed by inserting the returned device into a known good mating guide instrument and no issues were noted.No problem was found with the returned device.

• 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: 21149049
• Report Number: 1220246-2025-09434
• Device Sequence Number: 9645984
• Product Code: MBI
• UDI-Device Identifier: 00888867284814
• UDI-Public: (01)00888867284814(11)240523(17)290430(10)15252997
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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-3600-1
• Device Lot Number: 15252997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown