BIORCI 7207918Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010485540), received between Jan 4, 2018 and Sep 25, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2020Break; Break

  IT WAS REPORTED THAT DURING AND ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, INTERNAL TO THE PATIENT, A PROBLEM WAS DETECTED AT THE TIME OF FIXING THE GRAFT WITH THE BIORCI SCREW. THE 8 MM X 20 MM SCREW DID NOT ENTER IN THE GRAFTED SPACE. IT WAS INDICATED THAT THE SCREW GOT BROKEN, ALL PIECES WERE REMOVED. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A SMALLER SIZE SCREW (7MM X 20MM) AS A BACK-UP DEVICE. NO ADDITIONAL BONE HOLES WERE NEEDED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10587071 ↗
• MalfunctionSep 25, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A LCA RECONSTRUCTION BY ARTHROSCOPY, THE DEVICE TIP BROKE INSIDE THE PATIENT. ALL PIECES WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9120928 ↗
• MalfunctionJan 4, 2018Loose or Intermittent Connection; Component Missing

  IT WAS REPORTED THAT DURING THE SURGERY, THE DOCTOR USED THE GUIDES AND DRILL BITS, WHICH ARE NEEDED TO PLACE THE 8X20 SCREW, BUT AT THE MOMENT OF PLACING IT, IT WAS LOOSE AND THE GRAFT WAS LOOSED TOO, FOR THIS REASON, THEY DECIDED TO REMOVE IT IN ORDER TO PUT IT BACK AGAIN, BUT THE NOTICED THAT THE TIP WAS MISSING A PIECE. THEN, THEY PROCEEDED TO REMOVE WHAT WAS LEFT OF THE SCREW INSIDE THE PATIENT AND PLACE A 9X30 SCREW, WHICH WORKED PROPERLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7163491 ↗