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

Model Number	SP FIBERTAK RC, DBLOAD 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	10/21/2025
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 shoulder surgery the suture pulled out and did not hold.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: b5, d9, g3, h3, h6.The complaint cannot be confirmed as no evidence of the failure was received.One unpackaged ar-3632sp-1 batch 15395306 was received for evaluation.Visual inspection of the returned inserter revealed no damage, such as a bent shaft, a detached shaft from the handle, or broken parts.Functional testing was performed by gently pulling the inserter and checking for any issues.It was noted that the inserter is perfectly attached to the handle and not moving.No problem found with the returned device.
Event or Problem Description
***update, khe, 28-oct-2025.Further information received with the incoming delivery document.It was reported that the anchor was torn out during placement.

• Brand Name: SP FIBERTAK RC, DBLOAD 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: 23378757
• Report Number: 1220246-2025-04805
• Device Sequence Number: 9202517
• Product Code: MBI
• UDI-Device Identifier: 00888867341890
• UDI-Public: (01)00888867341890(11)250225(17)300131(10)15395306
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K251809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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: SP FIBERTAK RC, DBLOAD TAPE BL/W, BLK/W
• Device Catalogue Number: AR-3632SP-1
• Device Lot Number: 15395306
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• 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