MAUDE Adverse Event Report: ARTHREX, INC. SUPERMX NITI STAPLE W/ INSTRS, 18W X 18L; STAPLE, FIXATION, BONE

Model Number	SUPERMX NITI STAPLE W/ INSTRS, 18W X 18L
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported by a patient that two arthrex staples had been used during her foot surgery.One staple has been found to be broken.Patient states that the surgeon does not appear to be very concerned about the broken device.Specific arthrex part number was not provided at time of initial report.
Additional Manufacturer Narrative
The product quality complaint allegation has been confirmed upon receipt of the provided x-ray visualization.It was identified from the x-ray that a staple of an unknown part number had broken intra-operatively.No further information is available from the x-ray provided.The most likely cause of the event remains undetermined, as the unknown device is not expected to be returned for investigation.It was recorded that the event did not occur during the procedure, and additionally, the level of patient compliance was unknown.

• Brand Name: SUPERMX NITI STAPLE W/ INSTRS, 18W X 18L
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11483957
• Report Number: 1220246-2021-02730
• Device Sequence Number: 3844756
• Product Code: JDR
• UDI-Device Identifier: 00888867300880
• UDI-Public: 00888867300880
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K203180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SUPERMX NITI STAPLE W/ INSTRS, 18W X 18L
• Device Catalogue Number: AR-8719MXDS-1818
• Device Lot Number: 0051101455
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2021
• Supplement Date Received by Manufacturer: 02/28/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 08/27/2021
• Patient Sequence Number: 1