MAUDE Adverse Event Report: ARTHREX, INC. SUPERMX COMPRESSION STAPLE, 15W X 15L; STAPLE, FIXATION, BONE

Model Number	SUPERMX COMPRESSION STAPLE, 15W X 15L
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a lapidus arthrodese surgery the staple did fell of from the holder and could not be re-attached.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.24-mar-2023 update dw: further information were provided that the span fell off and then can not get back on it prior to use on the patient.
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.Complaint is not confirmed.Visual evaluation noted scratches on the returned staple.The staple delivery device was not returned for investigation.Functional testing showed that the returned staple was able to attach to the matting delivery device.The most likely cause of this event is misuse due to user error.

• Brand Name: SUPERMX COMPRESSION STAPLE, 15W 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: 19576084
• Report Number: 1220246-2024-06293
• Device Sequence Number: 18266027
• Product Code: JDR
• UDI-Device Identifier: 00888867300927
• UDI-Public: 00888867300927
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SUPERMX COMPRESSION STAPLE, 15W X 15L
• Device Catalogue Number: AR-8719MX-1515
• Device Lot Number: 2265125353
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown