MULTILOC 03.019.003Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982069382), received between Dec 3, 2025 and Dec 3, 2025 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 3, 2025Contamination /Decontamination Problem; Device-Device Incompatibility; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN ORIF FOR PROXIMAL HUMERUS FRACTURE WITH THE REAMER. WHEN THE SURGEON TRIED TO USE THE REAMER OVER A GUIDE WIRE WITH A STOPPER, THE GUIDE WIRE WOULD NOT PASS THROUGH THE HOLLOW PART OF THE REAMER. WHEN THE SURGEON TRIED TO REMOVE THE GUIDE WIRE FROM THE PATIENT'S BODY AND PASS IT THROUGH THE REAMER, THE GUIDE WIRE AGAIN APPEARED TO BE CLOGGED AND WOULD NOT PASS THROUGH THE HOLLOW PART OF THE REAMER. AS A RESULT, THE USE OF THE AFFECTED PRODUCT WAS ABANDONED AND THE SURGERY WAS PERFORMED USING CROWN REAMER 11.5MM (03.019.004). THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINS OF DELAY. THE NURSE AND SURGEON AT THE SCENE OF THE INCIDENT COMMENTED THAT IT WAS LIKELY THAT A FOREIGN OBJECT HAD ALREADY BEEN LODGED IN THE HOLLOW PART AT THE TIME OF SHIPMENT. THE HOSPITAL APPARENTLY STERILIZES INSTRUMENTS WITHOUT CLEANING THEM AFTER DELIVERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23703956 ↗