MAUDE Adverse Event Report: ARTHREX, INC. SP FBRTAK RC TGRTPE WH/BLK & STTPE WH/BL; NON-DEGRADABLE FIXATN FASTENER

Model Number	SP FBRTAK RC TGRTPE WH/BLK & STTPE WH/BL
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	01/12/2026
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 14-jan-2026, a sales representative reported via email that an ar-3652sp fibertak rc suture anchor experienced an issue during use.During an arthroscopic rotator cuff repair on (b)(6) 2026, the anchor was inserted into the greater tuberosity and secured as intended.Upon securing the implant, the surgeon observed that the swaged 1.7 mm suturetape slid within the anchor, while the 1.3 mm suturetape remained static and did not slide.The anchor itself remained secure and maintained its position, allowing the surgeon to proceed with the repair using the sutures from the anchor.There was no patient harm reported.Additional information was received on 19-jan-2026: after insertion of the anchor, while positioning the sutures for passage through the cuff, the surgeon noted that the 1.7 suturetape was sliding rather than the 1.3 suturetape.No fraying, loosening, or separation of the suture was observed.The procedure was completed using ar-3652 fibertak rc suture anchors, with additional arthrex swivelock implants used.There was no case delay or additional anesthesia administered.
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 returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is a use error, including incorrect surgical technique associated with the device.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: SP FBRTAK RC TGRTPE WH/BLK & STTPE WH/BL
• 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: 24257670
• Report Number: 1220246-2026-00399
• Device Sequence Number: 18224594
• Product Code: MBI
• UDI-Device Identifier: 00888867362901
• UDI-Public: (01)00888867362901(11)240606(17)290531(10)15270421
• Combination Product (Y/N): N
• PMA/510(K) Number: K251809
• 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): 05/20/2026

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 FBRTAK RC TGRTPE WH/BLK & STTPE WH/BL
• Device Catalogue Number: AR-3652SP
• Device Lot Number: 15270421
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2024
• 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