MAUDE Adverse Event Report: Arthrex, Inc. SUTURE ANCHOR, PEEK PUSHLOCK; BONE FIXATION SCREW/PLATE

Model Number	SUTURE ANCHOR, PEEK PUSHLOCK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 08-sep-2026, an arthrex subsidiary employee reported via email that an ar-1923ps suture anchor, peek pushlock (2.9 mm x 15.5 mm), experienced an issue during an ankle procedure performed on 02-sep-2026.A #2 fiberwire was passed using a suturelasso and secured with a pushlock anchor.During fixation assessment, the anchor appeared secure; however, the sutures did not provide the expected fixation.Further evaluation revealed that the tip of the anchor had broken off while the sutures remained within the anchor hole.A second anchor was implanted; however, adequate suture fixation was again not achieved.The sutures were re-passed using a suturelasso, and during fixation it was observed that the anchor had shifted out of position.The anchor was completely removed with the suture intact.The anchor site was re-prepared, and another anchor was implanted.The sutures were again passed using a suturelasso, and adequate final fixation was confirmed.The procedure was completed successfully.Due to the complication encountered during the procedure, an additional dose of anesthesia was administered.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: SUTURE ANCHOR, PEEK PUSHLOCK
• Common Device Name: BONE FIXATION SCREW/PLATE
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50801389
• Report Number: 1220246-2026-04770
• Device Sequence Number: 8643682
• Product Code: MBI
• UDI-Device Identifier: 00888867023147
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K251145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: SUTURE ANCHOR, PEEK PUSHLOCK
• Device Catalogue Number: AR-1923PS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2025
• 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