MAUDE Adverse Event Report: ARTHREX, INC. SUPERMX NITI STAPLE W/ INSTRS, 20W X 15L; STAPLE, FIXATION, BONE

Model Number	SUPERMX NITI STAPLE W/ INSTRS, 20W X 15L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the surgery the device broke in the foot.The cause is not known and at this stage there is no known non-union.No further information received.Update avoe 06-may-2022 it was confirmed that the initial surgery took place on the (b)(6) 2022 and the breakage was noticed with an x-ray during a control after the surgery.Currently the patient has no symptoms of pain or discomfort.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint is confirmed.No device was returned.Two x-rays of the implanted ar-8719mxds-2015 were provided.Upon inspection of the x-ray images, the device was noted as broken.Without return of the device, the most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: SUPERMX NITI STAPLE W/ INSTRS, 20W X 15L
• Common Device Name: STAPLE, FIXATION, BONE
• 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: 19369490
• Report Number: 1220246-2024-03626
• Device Sequence Number: 15375707
• Product Code: JDR
• UDI-Device Identifier: 00888867300897
• UDI-Public: 00888867300897
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K203180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2024

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: SUPERMX NITI STAPLE W/ INSTRS, 20W X 15L
• Device Catalogue Number: AR-8719MXDS-2015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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