MicroAire® 1600-645Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847399001429), received between Oct 8, 2019 and Sep 24, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K863734); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  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.

  Patient problems: Osteomyelitis

  MAUDE report 15480611 ↗
• MalfunctionOct 8, 2019Break

  DURING THE PROCEDURE SURGEON WAS DRILLING WITH A 0.045" K-WIRE INTO THE PATIENT'S RIGHT INDEX FINGER. THE K-WIRE BROKE INTO TWO PIECES. ONE PIECE REMAINED IN PATIENT AND REMOVED BY SURGEON. BOTH PIECES SEQUESTERED. X-RAY OF RIGHT HAND PERFORMED PER HOSPITAL POLICY. RESULTS CALLED TO SURGEON. PROCEDURE COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9166181 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K863734. One submission often covers many models, so check the product and lot details in each record.

• Z-1407-2017 · Feb 21, 2017 · Terminated
  MicroAire K-Wires