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

Model Number	SUTURE ANCHOR, PUSHLOCK
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/02/2026
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
It was reported that during a surgery the eyelid was pulled out from the implant when the sutures were cut.The anchor body remained inside the patient.There was no harm for patient, operator or third party reported.No further information received.Update 15-apr-26: further information was provided that clarifies the original description.It was reported that during a rotator cuff repair surgery, the eyelet was pulled out from the implant when the sutures were cut.It is believed that the anchor body broke and afterwards the eyelet was pulled out from the implant.The anchor body remains in the patient with sutures tightened.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: SUTURE ANCHOR, 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: 24965098
• Report Number: 1220246-2026-02383
• Device Sequence Number: 10463973
• Product Code: MBI
• UDI-Device Identifier: 00888867022959
• UDI-Public: (01)00888867022959(11)250925(17)300831(10)15503924
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/23/2026

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, PUSHLOCK
• Device Catalogue Number: AR-1922PS
• Device Lot Number: 15503924
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2025
• 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