MAUDE Adverse Event Report: MICROAIRE SURGICAL INSTRUMENTS, LLC MICROAIRE K-WIRE; K-WIRE 1.1MM(0.045")X152MM(6"),

Model Number 1600-645

Device Problem Insufficient Information (3190)

Patient Problem Osteomyelitis (4533)

Event Date 07/14/2022

Event Type  Injury  

Event Description

A 28 year old required surgery of the right hand to address a 5th metacarpal fracture on (b)(6) 2022.At a post operative appointment ther was significant edema noth throughout the dorsal aspect of the right hand.Additional mri imaging was concerning for osteomyelitis.Patient was prescribed an additonal antibiotic to take for 28 days during a trip abroad and patient was to return for another post operative check upon his return to the states.Microaire surgical instruments, llc would like to note that another incidenty with another patient resulted in an infection that required mri imagings, debridement surgery, oral antiobiotic treatment, and 6 weekds of iv antibiotic treatment for osteomyelitis.The prior incident was on microaire report 2020601-2022-00005.Both patients were treated by dr.Ryan tarr at orthonc asc.

Event Description

A 28 year old required surgery of the right hand to address a 5th metacarpal fracture on (b)(6) 2022.At a post operative appointment there was significant edema throughout the dorsal aspect of the right hand.Additional mri imaging was concerning for osteomyelitits.Patient was prescribed an additional antibiotic to take for 28 days during a trip abroad and patient was to return for another post operative check upon his return to the states.Microaire surgical instruments, llc would like to note that another incident with another patient resulted in an infection that required mri imagings, debridement surgery, oral antibiotic treatment, and 6 weeks of iv antibiotic treatment for osteomyelitis.The prior incident was on microaire report 2020601-2022-00005.Both patients were treated by dr.Ryan tarr at orthonc asc.

• Brand Name: MICROAIRE K-WIRE
• Type of Device: K-WIRE 1.1MM(0.045")X152MM(6"),
• Manufacturer (Section D): MICROAIRE SURGICAL INSTRUMENTS, LLC; 3590 grand forks boulevard; charlottesville VA 22911
• Manufacturer (Section G): MICROAIRE SURGICAL INSTRUMENTS, LLC; 3590 grand forks boulevard; charlottesville VA 22911
• Manufacturer Contact: erin knight ; 3590 grand forks boulevard; charlottesville, VA 22911 ; 4349758389
• MDR Report Key: 15480611
• MDR Text Key: 300570463
• Report Number: 2020601-2022-00006
• Device Sequence Number: 1
• Product Code: HXS
• UDI-Device Identifier: 00847399001429
• UDI-Public: (01)00847399001429
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1600-645
• Device Catalogue Number: 1600-645
• Device Lot Number: 1021364293
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2021
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Sex: Male