BIORAPTOR 72201395Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010595546), received between Mar 15, 2019 and Oct 18, 2021 — classified as 2 injuries, 2 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ASK SHOULDER, THE TIP OF THE SPADE DRILL BIT BROKE OFF IN THE GLENOID. IT BROKE OFF IN SUCH A WAY THAT IT SANK INTO THE BONE AND WAS NO LONGER VISIBLE. PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12647806 ↗
• InjurySep 20, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, USING THE SPADE DRILL BIT FOR ANCHOR, AT THE TIME OF MILLING IT LOOSENED METAL FILINGS. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12499771 ↗
• MalfunctionAug 23, 2019Flaked; Flaked

  IT WAS REPORTED THAT THE DEVICE WAS PEELED OFF WHEN SCREWING THE BONE. NO DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8927980 ↗
• MalfunctionMar 15, 2019Break

  IT WAS REPORTED THAT DURING HIP ARTHROSCOPY LABRAL REPAIR, DRILL TIP BROKE AND REMAINED IN PATIENTS BONE AS UNABLE TO RETRIEVE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8425135 ↗