MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE NITI STAPLE W/INSTRS 9WX10L; STAPLE, FIXATION, BONE

Model Number	DYNANITE NITI STAPLE W/INSTRS 9WX10L
Health Effect - Clinical Codes	Bacterial Infection (1735); Pain (1994); Swelling (2091); Discomfort (2330)
Date of Event	04/24/2020
Type of Reportable Event	Serious Injury
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 that a patient had a bunion correction surgery on (b)(6) 2020.During the surgery, the surgeon implanted ar-8717ds-0910 dynanite niti staple (lot: 926197317) to fix the osteotomy.The patient experienced infection and swelling post op.The surgeon treated the patient with rounds of antibiotics, before ultimately deciding to perform a hardware removal.The removal procedure took place on (b)(6) 2020.The revision surgery was performed by the same surgeon who performed the primary surgery, and took place at the same facility.There was no need for additional hardware as the fusion site had healed and there was no infection in the bone, just surrounding soft tissue which was sent for biopsy.The rep reported the bone was not affected during this procedure, and actually had a great fusion.Additional information received on 4/29/2020: it was reported that ar-8717ds-0910 (lot: 926197317) was the only arthrex product implanted during the primary surgery, and the only arthrex product removed during the revision surgery.The patient started experiencing a reaction/pain and discomfort on (b)(6) 2020.The patient was experiencing redness and swelling.Cultures were taken in office, and again during surgery.The patient tested positive for staphylococcus.There are no de-identified x-ray copies available.

• Brand Name: DYNANITE NITI STAPLE W/INSTRS 9WX10L
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10055733
• Report Number: 1220246-2020-01837
• Device Sequence Number: 14156295
• Product Code: JDR
• UDI-Device Identifier: 00888867288058
• UDI-Public: 00888867288058
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K172052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/14/2020

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 Expiration Date: 09/30/2024
• Device Model Number: DYNANITE NITI STAPLE W/INSTRS 9WX10L
• Device Catalogue Number: AR-8717DS-0910
• Device Lot Number: 926197317
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 05/14/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Other