RAD® 1883670HSRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 20681490692810), received between Jul 19, 2017 and Apr 8, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19057296 ↗
• MalfunctionSep 26, 2023Break; Break

  IT WAS REPORTED THAT DURING INTRA-OP OF ENDOSCOPIC CRANIOFACIAL RESECTION THE TIP OF THE BUR SNAPPED WHILE DRILLING THE BONE. PROCEDURE WAS DELAYED BY 30 MINUTES. PROCEDURE WAS COMPLETED WITH BACK UP PRODUCT. THERE WAS NO PATIENT INJURY. AS PER THE ANALYSIS FINDINGS OF THE BUR, THE SPIRAL WRAP OF THE BUR EXTENDED, THERE WAS NO EVIDENCE THAT THE BUR WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17816502 ↗
• MalfunctionJul 12, 2023Break; Overheating of Device; Break; Overheating of Device

  IT WAS REPORTED THAT DURING PROCEDURE WHEN GRINDING THE FRONTAL SINUSES, THE TIP OF THE BUR BECAME HOT AND THE SPIRAL WRAP FROM THE INNER SHAFT OF THE DRILL BIT BROKE. THERE WAS NO FRAGMENTS DETACHED FROM BUR. THE PROCEDURE WAS COMPLETED BY CONVENTIONAL SURGICAL DEVICE. NO PROCEDURE DELAY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17305498 ↗
• MalfunctionMay 27, 2022Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE THE SURGEON USE HANDPIECE WITH BUR FOR SINUS SURGERY. THE BUR HAS BEEN BROKEN. PRODUCT HAVE CONTACT WITH THE PATIENT. NO BROKEN PIECES OF THE REPORTED PRODUCT REMAIN INSIDE THE PATIENT'S BODY. THERE WAS NO DELAY IN SURGERY. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14520653 ↗
• MalfunctionSep 9, 2020Break; Break

  ADDITIONAL INFORMATION RECEIVED MENTIONED THAT THE TIP BROKE BUT WAS NOT DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10506399 ↗
• MalfunctionFeb 1, 2019Break; Break

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA A REGULATORY BODY THAT THE BUR WAS BROKEN DURING USE. THE BUR BROKE AFTER A FEW SECONDS OF USE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8298877 ↗
• MalfunctionFeb 1, 2019Break; Break

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA A REGULATORY BODY THAT THE BUR WAS BROKEN DURING USE. THE BUR HAD BEEN IN USE FOR APPROXIMATELY 15 MINUTES BEFORE IT WAS BROKEN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8298749 ↗
• MalfunctionDec 28, 2018Break; Break

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE BUR WAS BROKEN DURING THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8203007 ↗
• MalfunctionDec 27, 2017Break; Break

  THE CUSTOMER REPORTED THREE HIGH SPEED BURS BROKE WITHIN THIRTY SECONDS AFTER USE DURING A PROCEDURE. THIS REPORT REPRESENT BUR 3 OF 3.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7148962 ↗
• MalfunctionDec 27, 2017Break; Break

  THE CUSTOMER REPORTED THREE HIGH SPEED BURS BROKE WITHIN THIRTY SECONDS OF USE DURING A PROCEDURE. THIS REPORT REPRESENTS BUR 2 OF 3.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7148923 ↗
• MalfunctionDec 27, 2017Break; Break

  THE CUSTOMER REPORTED THREE HIGH SPEED BURS BROKE WITHIN THIRTY SECONDS OF USE DURING A PROCEDURE. THIS REPORT REPRESENTS BUR 1 OF 3.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7148831 ↗
• MalfunctionAug 31, 2017Material Fragmentation; Material Fragmentation

  THE SURGEON REPORTED THAT "DURING A SINUS SURGERY, THE BUR WAS USED TO MILL THE NASAL BONE (OPENING OF THE FRONTAL SINUS FLOOR) AND AFTER 45 MINUTES THE BUR BROKE OFF FROM THE ROD AND WAS EJECTED INTO THE BOTTOM OF THE FRONTAL SINUS (PLACED JUST IN FRONT OF THE BRAIN AND ABOVE THE EYE SOCKETS). THE BUR WAS REMOVED WITH A CLAMP. SECOND BUR USED TO CONTINUE THE PROCEDURE: DISLOCATION FROM THE ROD"; WHICH WAS CONFIRMED TO BE A STRETCHED SPIRAL WRAP, NO FRAGMENTS DETACHED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6836069 ↗
• MalfunctionAug 31, 2017Material Fragmentation; Material Fragmentation

  ADDITIONAL INFORMATION RECEIVED: IT WAS INITIALLY BELIEVED THAT THE FACILITY HAD DISCARDED THE BURS; HOWEVER, THEY HAD BEEN GIVEN TO THE PHARMACIST FOR RETURN AND HAVE SINCE BEEN RECEIVED. IT WAS ALSO CONFIRMED THAT THERE WERE 2 BURS THAT HAD THE "INNER ROD DRAWN"; A TOTAL OF 3 BURS WERE USED FOR THE PROCEDURE. THIS MDR WAS FILED TO REPORT THE BUR THAT HAD THE DETACHED TIP THAT REQUIRED RETRIEVAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6835809 ↗
• MalfunctionJul 19, 2017Break; Break

  ADDITIONAL INFORMATION PROVIDED BY THE SALES REP INDICATES THAT THE BUR BROKE INTO TWO PIECES AFTER BEING LOADED ONTO THE HANDPIECE. IT WAS CONFIRMED THAT THE BUR WAS NOT FRACTURED PRIOR TO BEING REMOVED FROM ITS ORIGINAL PACKAGING. THE BREAK DID NOT RESULT IN A FRAGMENT THAT REQUIRED RETRIEVAL FROM THE PATIENT. A REPLACEMENT BUR WAS USED TO COMPLETE THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6725336 ↗