BIORAPTOR 72201108Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010595034), received between Jun 15, 2020 and Jan 8, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2026Break

  DURING A HIP ARTHROSCOPY PROCEDURE, THE 2.6 MM BIORAPTOR DRILL BIT BROKE INSIDE THE PATIENT. A REPLACEMENT DEVICE FROM A COMPETITOR (ARTHREX) WAS USED TO CONTINUE THE PROCEDURE. THE SURGERY WAS DELAYED FOR MORE THAN AN HOUR WHILE ALL FRAGMENTS OF THE BROKEN DRILL BIT WERE LOCATED AND REMOVED. THE BROKEN PIECES WERE REMOVED USING A DISC CLAMP (3 MM DIAMETER). NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24003213 ↗
• InjuryJun 12, 2025Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, AFTER DRILLING THE BONE, THE TIP OF A BIORAPTOR DRILL WAS MISSING. LOOKING UNDER X-RAY, IT WAS NOTICED THAT THE TIP WAS IN THE BONE. IT COULD NOT BE REMOVED AND WAS LEFT IN THE PATIENT'S BONE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE, INSTEAD. THERE WAS A DELAY OF 20 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22199915 ↗
• MalfunctionNov 1, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN DRILLING TO PLACE THE BIORAPTOR SUTURE ANCHOR, THE TABLE INTRODUCER BROKE. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY, BUT IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20593287 ↗
• MalfunctionApr 30, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN USING 2.6MM DRILL BIT SPADE FOR THE 2.3MM BIORAPTOR SUTURE ANCHOR TO PREPARE HOLE FOR OSTEORAPTOR 2.3 ANCHOR - DRILL HAD BEEN USED FOR HOLE PREPARATION OF 2 ANCHORS IN PATIENT ALREADY. WHILE DRILLING 3RD HOLE WITH USE OF DRILL GUIDE, THE BLADE OF THE DRILL SNAPPED OFF AND LODGED IN PATIENT'S CORTICAL BONE. THE BODY OF THE DRILL WAS REMOVED STILL ATTACHED TO THE JACOBS CHUCK AND HANDPIECE. THE BLADE/HEAD OF THE DRILL LODGED IN THE BONE WAS REMOVED WITH AN ALLIGATOR GRASPER. IT WAS BELIEVED THAT THE BREAK WAS CLEAN AS NO OTHER PARTS OF THE DRILL COULD BE SEEN. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19214397 ↗
• InjuryJun 15, 2020Material Fragmentation; Appropriate Device Problem Term/Code Not Available; Material Fragmentation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DRILL WAS DROPPING EMALIA. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE. NO DELAY AND NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient; Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10151813 ↗