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

Model Number DYNANITE NITI STAPLE W/INSTRS 9WX10L

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Erythema (1840); Pain (1994); Swelling (2091); Discomfort (2330); Reaction (2414)

Event Date 01/24/2020

Event Type  Injury  

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 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 rep reported that the removal surgery has not taken place as of yet, and is on the schedule.Additional information received on 4/29/2020: the sales rep reported ar-8717ds-0910 (lot: 926197317) was the only arthrex product implanted during the primary surgery.The revision surgery has not yet been scheduled.The surgeon does not plan to implant any additional arthrex hardware during the upcoming revision surgery.The patient started experiencing a reaction/pain and discomfort on (b)(6) 2020.The patient is experiencing swelling and redness.Cultures were taken, and the patient tested positive for staphylococcus and e.Coli.There are no de-identified x-ray copies available.

• Brand Name: DYNANITE NITI STAPLE W/INSTRS 9WX10L
• Type of Device: 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: vik bajnath ; 8009337001
• MDR Report Key: 10055750
• MDR Text Key: 193721905
• Report Number: 1220246-2020-01838
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00888867288058
• UDI-Public: 00888867288058
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 04/24/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other