MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, PEEK MINI PUSHLOCK; BONE FIXATION SCREW/PLATE

Model Number	SUTURE ANCHOR, PEEK MINI PUSHLOCK
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
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 10/13/2025, it was reported by an arthrex subsidiary employee via email that two ar-8825p peek mini pushlock anchors malfunctioned.The threaded portion of the anchor failed to enter the drill hole, despite being impacted according to the established technique.As a result, the tip of the first anchor fractured, preventing adequate fixation at the surgical site.This issue was discovered during a procedure performed on (b)(6) 2025.
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 user error, specifically improper bone preparation, excessive force, and/or incorrect surgical technique.The complaint allegation was not confirmed; the device was not received for evaluation, and no evidence of the failure was received.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.
Event or Problem Description
Additional information was received on 12/15/2025: during the procedure, a single complaint was reported involving one ar-8825p peek mini pushlock anchor that was found to be damaged.No additional product allegations were noted.There were no broken fragments inside the patient.Information on how the case was completed was not provided.The procedure was not delayed, and no additional anesthesia was administered.

• Brand Name: SUTURE ANCHOR, PEEK MINI PUSHLOCK
• 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: 23312627
• Report Number: 1220246-2025-04652
• Device Sequence Number: 5788823
• Product Code: MBI
• UDI-Device Identifier: 00888867046672
• UDI-Public: (01)00888867046672(11)231011(17)280930(10)15152903
• 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,Followup,Followup
• Report Date (Section B): 02/11/2026

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 MINI PUSHLOCK
• Device Catalogue Number: AR-8825P
• Device Lot Number: 15152903
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2025
• Supplement Date Received by Manufacturer: 12/15/2025; 02/09/2026
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 01/05/2026; 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown