FDA Adverse Event Injury Summary report: N

MICROAIRE K-WIRE

MDR report key: 15479162 · Received September 24, 2022

Report

Report Number
2020601-2022-00005
Event Type
Injury
Date Received
September 24, 2022
Date of Event
August 1, 2022
Report Date
March 2, 2023
Manufacturer
MICROAIRE SURGICAL INSTRUMENTS, LLC
Product Code
HXS
UDI-DI
00847399001426
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
NC, US
Reporter Occupation
003

Narratives

Description of Event or Problem · 0

A 66 YEAR OLD REQUIRED ADDITONAL MRI IMAGING AND ORAL ANTIBIOTIC TREATMENT, PLACEMENT OF ANTIBIOTIC BEADS AND 6 WEEKS OF IV ANTIBIOTIC THERAPY TO TREAT 4TH MCP JOINT SEPTIC ARTHRITIS, PROXIMAL PHALANX OSETEOMYELITIS AND DEEP SOFT TISSUE ABSCESS ALONG SITE OF 4TH PROXIMAL PHALANX. MICROAIRE SURGICAL INSTRUMENTS WOULD LIKE TO NOTE THAT SECOND INCIDENT WITH ANOTHER PATIENT RESULTED IN INFECTION THAT REQUIRED MRI IMAGING AND ORAL ANTIBIOTIC TREATEMENT FOR OSTEOMYELITIS, MICROAIRE REPORT 2020601-2022-00006. BOTH PATIENTS WERE TREATED BY DR. RYAN TARR AT ORTHONC ASC.

Description of Event or Problem · 0

A 66 YEAR OLD REQUIRED ADDITIONAL MRI IMAGING AND ORAL ANTIOBIOTIC TREATMENT, PLACEMENT OF ANTIBIOTIC BEADS AND 6 WEEKS OF IV ANTIBIOTIC THERAPY TO TREAT A 4TH MCP JOINT SEPTIC ARTHRITIS, PROXIMAL PHALANX OSTEOMYLITIS AND DEEP SOFT TISSUE ABSCESS ALONG SITE OF 4TH PROXIMAL PHALANX. MICROAIRE SURGICAL INSTRUMENTS, LLC, WOULD LIKE TO NOTES THAT A SECOND INCIDENT WITH ANOTHER PATIENT RESULTED IN INFECTION THAT REQUIRE MRI IMAGING AND ORAL ANTIBIOTIC TREATMENT FOR OSTEOMYELITIS ON MICROAIRE REPORT 2020601-2022-00006. BOTH PATIENTS WERE TREATED BY DR. RYAN TARR AT ORTHONC ASC.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1604180 MICROAIRE K-WIRE K-WIRE 1.1MM(0.045")X152(6") HXS MICROAIRE SURGICAL INSTRUMENTS, LLC 1600-645 1021364748 00847399001426

Patients

Seq Age Sex Outcome Treatment
1 66 YR Unknown Hospitalization