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	Failure to Advance (2524)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 13-aug-2026, a sales representative reported via email that an ar-8825bc mini biocomposite pushlock suture anchor (2.5 mm × 8 mm) experienced an issue during a procedure performed on (b)(6) 2026.While inserting the anchor for a repair, the surgeon placed the anchor into bone hole and removed the orange tab.When attempting to seat the anchor by malleting the driver, the driver would not advance.Multiple attempts were made, but the driver remained unable to advance the anchor.The patient outcome was not reported.Additional information was received on (b)(6) 2026: the procedure being performed was a wrist arthroscopy with tfcc repair.The eyelet was fully seated in the bone; however, the anchor would not advance further into the bone.No excessive resistance was encountered during insertion, and no visible damage was observed on either the anchor or the driver.The affected implant was removed.The eyelet could not be removed and remained implanted in the patient.Another ar-8825bc was used to successfully complete the procedure.The event did not result in a surgical delay beyond the time required to open a replacement implant, and no additional anesthesia was administered.No breakage of the implant or instrument was observed or reported.No patient injury or adverse outcome was reported as a result of the event.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• 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 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50473843
• Report Number: 1220246-2026-04507
• Device Sequence Number: 10203823
• Product Code: MAI
• UDI-Device Identifier: 00888867247901
• UDI-Public: (01)00888867247901(11)251020(17)270930(10)15516399
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K253931
• 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
• Report Date (Section B): 08/27/2026

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
• Device Lot Number: 15516399
• 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: 08/13/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown