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

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 05/16/2023

Event Type  Injury  

Event Description

On 06/27/2023, it was reported by a relative of a patient, via phone, that the patient is experiencing a reaction 3 weeks after undergoing a right de rotational femoral osteotomy with allograft and mpsl reconstruction with allograft on (b)(6) 2023 in which (2) ar-8934bcst suture tapes, an ar-8719mxds-2015 dynanite staple, and an ar-4030p-07 peek interference screw were implanted.The patient was admitted to the hospital after experiencing a breakout of hives.The patient is being treated with steroids and other antihistamines that are keeping her stable.The patient is awaiting allergy testing.There was no additional information provided additional information was requested.

Manufacturer Narrative

The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.

• Brand Name: SUPERMX NITI STAPLE W/ INSTRS, 20W X 15L
• 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: emily shafer ; 8009337001
• MDR Report Key: 17378415
• MDR Text Key: 319748396
• Report Number: 1220246-2023-07263
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00888867300897
• UDI-Public: 00888867300897
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SUPERMX NITI STAPLE W/ INSTRS, 20W X 15L
• Device Catalogue Number: AR-8719MXDS-2015
• Device Lot Number: 2206123789
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2023
• Date Device Manufactured: 08/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other