NA 03.110.002.99Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034711522), received between Oct 3, 2023 and Oct 3, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 3, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. BEFORE SURGERY, WHEN THE INSTRUMENT SET WAS TAKEN OUT OF THE CARDBOARD BOX IT WAS SHIPPED IN TO STERILIZE IT, THERE WAS A CITRUS SMELL COMING FROM THE INSTRUMENT SET. AFTER WASHING AND STERILIZING THE INSTRUMENT SET, THE CITRUS SMELL BECAME EVEN STRONGER. THEREFORE, THE INSTRUMENT SET WAS NOT USED, AND A DIFFERENT SET OF THE SAME COMPONENTS WERE USED IN THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT STATUS/ OUTCOME: STABLE. NO FURTHER INFORMATION IS AVAILABLE. NOTE: SINCE IT IS NOT POSSIBLE TO DETERMINE WHAT IS CAUSING THE CITRUS SMELL, ONE OF THE COMPONENTS WAS TEMPORARILY REGISTERED AS AN IMPACTED PRODUCT. THIS REPORT IS FOR ONE (1) TORQUE LIMITER 1.2NM W/AO/ASIF-QC THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17864932 ↗