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

Model Number	SUTURE ANCHOR, MINI BC PUSHLOCK
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/27/2025, an arthrex subsidiary employee reported via email that an ar-8825bc biocomposite pushlock mini suture anchor became unusable when the tip of the anchor detached as the tape was sutured through.The surgery was completed using a replacement ar-8825bc biocomposite pushlock mini suture anchor.No breakage occurred within the patient during use.There was no significant delay in the procedure, no additional anesthesia was administered, and no adverse effects were reported.This issue was identified during a procedure performed on (b)(6) 2025, with no patient harm reported.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-8825bc pushlock batch 15378388 was received for investigation.Visual inspection identified that only the driver and the eyelet were returned for evaluation.Functional testing could not be performed due to the device's damage.The most likely cause for the reported failure is user-related handling during suture passage.The tip of the pushlock mini suture anchor detached while the tape was being sutured through, which is consistent with excessive or off-axis force applied to the anchor during suture shuttling or tape passage.The complaint allegation that the anchor detached is confirmed.

• Brand Name: SUTURE ANCHOR, MINI BC 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: 23084041
• Report Number: 1220246-2025-03910
• Device Sequence Number: 4786232
• Product Code: MAI
• UDI-Device Identifier: 00888867247901
• UDI-Public: 00888867247901
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063479
• 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
• Report Date (Section B): 01/29/2026

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, MINI BC PUSHLOCK
• Device Catalogue Number: AR-8825BC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown