BIORCI 7209018Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010460059), received between Dec 20, 2021 and Jul 9, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• MalfunctionJul 9, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI-HA SCREW BROKE WHEN INSERTING INTO THE BONE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22465489 ↗
• InjuryDec 20, 2021Break; Break

  IT WAS REPORTED THAT DURING USE IN A R PCL RECONSTRUCTION, THE "SCR BIORCI-HA 10X35 STERILE" BROKE ON INSERTION, THE SURGEON DRILLED 9MM AND A HARD BONE WAS NOTED. ALL THE BROKEN PIECES WERE REMOVED WITHOUT ISSUE BY HAND. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE IN THE SAME BONE HOLE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13043522 ↗