MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK DOUBLE LOADED FW CL; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERTAK DOUBLE LOADED FW CL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a laterjet capsular suturing the suture broke when knotted.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.Update 04-sep 2024: further information was provided that the broken piece was retrieved out of the patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is not confirmed.Two packaged and unopened ar-3600-2 fibertak¿ suture anchor with #2 fiberwire batch number: 15211696 were received for investigation.The complaint device was discarded by the facility and is not available for return.Visual evaluation of the packaged devices noted no problems.Further visual evaluation after opening the packaging of the devices also did not note any problems.Functional testing was performed by testing the movement of the sutures within the anchor sheath.No problems were noted during testing, as no friction or resistance was noted.Further functional testing was performed using a labrum model.The anchor of the device was inserted into the model using a known good ar-3610f batch number: 0072229 and a known good mallet.The suture was knotted onto the model labrum with no issues.No problem found.

• Brand Name: FIBERTAK DOUBLE LOADED FW CL
• 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: 20214907
• Report Number: 1220246-2024-07629
• Device Sequence Number: 7450767
• Product Code: MBI
• UDI-Device Identifier: 00888867206960
• UDI-Public: 00888867206960
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K181769
• 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): 02/04/2025

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 DOUBLE LOADED FW CL
• Device Catalogue Number: AR-3600-2
• Device Lot Number: 15211696
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2024
• 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