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

Model Number	FIBERTAK RC, DOUBLOAD TAPE BL/W, BLK/W
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
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 surgery the implant is not anchored.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 24-feb-2025: further information was provided that the anchor could not be fixated properly to the bone and it slipped out.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was not confirmed one unpackaged ar-3632-1 serial/batch (b)(6) was received for investigation.The device arrived for evaluation without the anchor; only the inserter was received.Visual evaluation revealed that the returned device was not bent or damaged.Functional testing cannot be performed as the suture/anchor was not returned, and testing cannot be performed on the received device.The most likely cause of the reported failure is a user error, specifically, improper bone preparation and/or surgical technique.Dfu-0054-eo bio-fastak, fastak¿, suturetak® and fibertak® suture anchors g.Precautions.6.Suturetak and fibertak suture anchors only: anchors loaded on flexible drivers: the drill guide tip must remain in contact with the bone surface during the drilling and implant impaction steps of the procedure.Failure to do so may result in difficulty seating the implant to its intended depth.Avoid excessive impaction during anchor insertion as this could lead.To inserter damage and/or breakage.If insertion resistance is encountered, do not impact harder.Replace the implant and repeat the drilling/insertion process.

• Brand Name: FIBERTAK RC, DOUBLOAD TAPE 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: 21471725
• Report Number: 1220246-2025-00704
• Device Sequence Number: 19706082
• Product Code: MBI
• UDI-Device Identifier: 00888867276918
• UDI-Public: (01)00888867276918(11)200122(17)251231(10)12540003
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K241235
• 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): 05/19/2025

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 Expiration Date: 12/31/2025
• Device Model Number: FIBERTAK RC, DOUBLOAD TAPE BL/W, BLK/W
• Device Catalogue Number: AR-3632-1
• Device Lot Number: 12540003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2020
• 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