AOS SMALL BONE REAMER Ø3.1 x 328mm 4020-031Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00848665028850), received between Oct 4, 2019 and Oct 4, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (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 18, 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.

• InjuryOct 4, 2019Material Fragmentation; Material Fragmentation

  ON (B)(6) A SURGERY TOOK PLACE FOR THE IMPLANT OF A FIBULAR NAIL P/N 1527-225. THE SALES REPRESENTATIVE REPORTED THAT DURING THE ROUTINE REAMING OF THE FIBULA, THE 3.1 MM SMALL BONE REAMER HEAD FRACTURED INTO MULTIPLE PIECES (P/N 4020-031). ALL BUT ONE PIECE WAS ABLE TO BE RETRIEVED. THE REMAINING PIECE WAS LODGED IN CORTICAL BONE, AND THE SURGEON DETERMINED THAT RETRIEVAL OF THE REMAINING PIECE WOULD CAUSE MORE DAMAGE THAN GOOD TO THE PATIENT. THOUGH THE LOT NUMBER WAS RETRIEVED FROM THE BROKEN REAMER, THE PARTS WERE NOT ABLE TO BE RETURNED FOR EVALUATION. THE PARTS WERE DISPOSED OF IMMEDIATELY AFTER THE SURGERY. AN ENGINEERING EVALUATION WAS UNABLE TO REPEAT THE FAILURE AS DESCRIBED, AND AN EXACT ROOT CAUSE IS UNKNOWN.

  Patient problems: Tissue Damage

  MAUDE report 9158835 ↗