MAUDE Adverse Event Report: ARTHREX, INC. SELF-PUNCHING TRIPLE LOADED FIBERTAK; NON-DEGRADABLE FIXATN FASTENER

Model Number	SELF-PUNCHING TRIPLE LOADED FIBERTAK
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
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
On 07/16/2025, a sales representative reported via email that an ar-3633sp fibertak sp suture anchor was used for the medial row during a supraspinatus tendon repair arthroscopic procedure on (b)(6) 2025.The anchor pulled out twice during placement, even after being reloaded and reinserted into the same hole in an attempt to set it again.The ar-3650ds drill was used with the orange 3.5 reusable drill guide, and the anchor was placed according to standard technique.Bone quality was moderate.An ar-1927pst-3 anchor was inserted in the same hole to complete the medial fixation.A 10-minute delay occurred.For the lateral row, an ar-2324kbcsp knotless biocomposite swivelock sp anchor was used, and the eyelet fractured through the side upon insertion.A total of three suture tapes were loaded into the eyelet.The hole was pre-punched with the silver punch, and light taps were used to initiate insertion.Bone quality was moderate to hard.An additional ar-2324kbcsp anchor was used to complete the lateral fixation.There was no patient harm reported.Additional information was received on 07/23/2025: the case was delayed a total of ten minutes due to both failed anchors, with ten minutes of additional anesthesia administered.All fragments of the fractured eyelet were retrieved from the patient.No adverse effects reported on or after the surgery.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude the most likely cause.The most likely cause of the reported failure is user error, including improper bone preparation and incorrect surgical technique during device application.These factors may have contributed to the malfunction or compromised the integrity of the implant during the procedure.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• Brand Name: SELF-PUNCHING TRIPLE LOADED FIBERTAK
• 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: 22720396
• Report Number: 1220246-2025-03259
• Device Sequence Number: 15848783
• Product Code: MBI
• UDI-Device Identifier: 00888867369962
• UDI-Public: (01)00888867369962(11)231215(17)281130(10)15181444
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K200341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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: SELF-PUNCHING TRIPLE LOADED FIBERTAK
• Device Catalogue Number: AR-3633SP
• Device Lot Number: 15181444
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown