MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, PEEK SUTURETAK 2.4X12.4MM; BONE FIXATION SCREW/PLATE

Model Number	SUTURE ANCHOR, PEEK SUTURETAK 2.4X12.4MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
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 11/21/2025, a sales representative reported via email that five ar-1934pf-24 peek suturetak suture anchors pulled out in a surgical case.This incident occurred during a procedure.Additional information was received on 11/25/2025: this occurred on (b)(6) 2025, during a rotator cuff repair with biceps tenodesis procedure.The case was completed using an ar-3632sp 2.6 fibertak sp soft anchor.The surgery was delayed by approximately 20 minutes, but no additional anesthesia was administered.Bone quality was reported as poor.A percutaneous 3.0 insertion kit was used to prepare the bone socket.No adverse patient effects were reported, and no photos or videos of the complaint device were provided.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause is attributed to poor bone quality and suboptimal bone preparation in a compromised bone environment, resulting in insufficient fixation strength and anchor pullout.

• Brand Name: SUTURE ANCHOR, PEEK SUTURETAK 2.4X12.4MM
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: 23759809
• Report Number: 1220246-2025-05529
• Device Sequence Number: 10079010
• Product Code: HWC
• UDI-Device Identifier: 00888867024120
• UDI-Public: (01)00888867024120(11)250714(17)300630(10)15466512
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• 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): 03/19/2026

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 SUTURETAK 2.4X12.4MM
• Device Catalogue Number: AR-1934PF-24
• Device Lot Number: 15466512
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2025
• 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