BIORAPTOR 72203280Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010656452), received between Mar 22, 2019 and Jul 26, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 29, 2024Open, Classified

   Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.

   Z-0581-2025 · Root cause: Package design/selection · Recall details · FDA record ↗

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.

• MalfunctionJul 26, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE BIORAPTOR ANCHOR BROKE DURING INSERTION. ALL COMPONENTS WERE REMOVED FROM PATIENT JOINT. IT IS UNKNOWN IF THERE WERE BACK UP DEVICES TO COMPLETE THE PROCEDURE, A NON SIGNIFICANT SURGICAL DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17402268 ↗
• MalfunctionApr 3, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE SHOULDER JOINT INSTABILITY PROCEDURE, WHEN THE SURGEON TRIED TO USE THE ANCHOR, IT DID NOT BEND AS THE SURGEON WOULD LIKE, WHEN HE TRIED TO BEND MORE, THE ANCHOR POPS UP AND BROKE. THE BROKEN PIECE WAS REMOVED WITH TWEEZERS FROM PATIENT. A BACKUP WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9921808 ↗
• MalfunctionMar 22, 2019Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A DRYING VS PROCEDURE FOUR BIORAPTOR ANCHORS WERE USED BUT THE FIFTH HAD AN ISSUE. THE ANCHOR EXCEEDED THE AREA APPLIED, THE DIAMETER OF THE ANCHOR HAS A STRUCTURE THAT DID NOT ALLOW TO ENTER TO THE TISSUE, FOR THIS REASON THE ANCHOR COULD NOT BE SECURED. AN ADDITIONAL BONE HOLE WAS REQUIRED, THERE WAS LOSS OF TISSUE AND A VOID WAS LEFT IN THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES.

  Patient problems: Tissue Damage

  MAUDE report 8446432 ↗