MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK, DOUBLOAD FW BL/W, BLK/W; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERTAK, DOUBLOAD FW BL/W, BLK/W
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
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 rotator cuff repair shoulder arthroscopy a seam of the device fell off the anchor.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.The complaint allegation is confirmed.One unpacked ar-3630-1 fibertak, doub load fw bl/w, blk/w serial/batch number (b)(6) was received for investigation.The device arrived without the sutures or anchor for evaluation.The visual evaluation of the shaft and handle inserter found marks closed to the tip of the inserter.Functional testing cannot be performed as the returned device is missing components.The most likely cause of the reported and observed failure is user error, specifically improper product-specific surgical technique.

• Brand Name: FIBERTAK, DOUBLOAD FW BL/W, BLK/W
• 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: 20797791
• Report Number: 1220246-2024-08663
• Device Sequence Number: 7883070
• Product Code: MBI
• UDI-Device Identifier: 00888867276871
• UDI-Public: (01)00888867276871(11)240312(17)290228(10)15219159
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 05/28/2025

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, DOUBLOAD FW BL/W, BLK/W
• Device Catalogue Number: AR-3630-1
• Device Lot Number: 15219159
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2024
• 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