RAD® 1883070HSRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 20681490464608), received between Feb 3, 2017 and Nov 14, 2024 — classified as 1 injury, 24 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2024Vibration; Vibration

  IT WAS REPORTED THAT AFTER USING THE DRILL FOR TEN MINUTES AT THE TIME OF THE DRAF PROCEDURE, THE DRILL WAS HOT AND THE MOTOR SOUNDED LIKE IT WAS MOVING, BUT WHEN THE DRILL WAS APPLIED TO THE AFFECTED AREA, IT STOPPED SPINNING AND WAS IDLE SPINNING. THERE WAS NO PATIENT IMPACT. AS PER THE BUR ANALYSIS, IT IS WOBBLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20681261 ↗
• MalfunctionNov 4, 2024Break; Break

  IT WAS REPORTED THAT DURING ENDOSCOPIC SINUS SURGERY, THREE BURS TIP WAS BROKEN. THERE WERE NO FRAGMENTS DETACHED FROM THE BURS. NUMBER OF ROTATIONS WAS 12000. ALL THE THREE BURS WERE USED WITH SAME M5 HANDPIECE. THERE WAS A PROCEDURAL DELAY OF TEN MINUTES AND THE SURGERY WAS COMPLETED USING ANOTHER BUR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20596123 ↗
• MalfunctionNov 4, 2024Break; Break

  IT WAS REPORTED THAT DURING ENDOSCOPIC SINUS SURGERY, THREE BURS TIP WAS BROKEN. THERE WERE NO FRAGMENTS DETACHED FROM THE BURS. NUMBER OF ROTATIONS WAS 12000. ALL THE THREE BURS WERE USED WITH SAME M5 HANDPIECE. THERE WAS A PROCEDURAL DELAY OF TEN MINUTES AND THE SURGERY WAS COMPLETED USING ANOTHER BUR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20596068 ↗
• MalfunctionSep 9, 2024Break; Vibration; Break; Vibration

  IT WAS REPORTED THAT INTRA-OPERATIVELY DURING ESS PROCEDURE, THE OUTER TUBE PORTION WAS DAMAGED. IT WAS CONFIRMED THAT THERE WAS NO RESIDUE IN THE BODY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20167520 ↗
• MalfunctionFeb 14, 2024Break; Break

  IT WAS REPORTED THAT INTRA OPERATIVE, BUR CAME OFF WHILE USING ON THE PATIENT. THERE WAS NO PATIENT IMPACT RELATED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18701211 ↗
• MalfunctionFeb 13, 2024Break; Break

  IT WAS REPORTED THAT PRE-OP, WHEN THE DOCTOR OPENED THE BUR FROM PACKAGE HE FOUND THAT THE TIP WAS BROKEN AND COULDN'T USE. OUTER PACKAGE WAS NOT DAMAGED WHEN RECEIVED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18693901 ↗
• MalfunctionAug 1, 2023Break; Break

  IT WAS REPORTED THAT DURING A SINUS PROCEDURE MD WAS UTILIZING A BUR WHICH BROKE DURING THE PROCEDURE. ALL PIECES WERE COLLECTED AND ACCOUNTED FOR. THE BUR WAS IMMEDIATELY REMOVED FROM THE STERILE FIELD. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17434133 ↗
• MalfunctionJul 6, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PROCEDURE SCRUB NURSE CONNECTED THE NEW BURR TO THE DEBRIDER HANDPIECE AND SURGEON BEFORE USING IT ON PATIENT PRESSED THE FOOTPEDAL. THE SPRING OF THE BURR TIP CAME OFF. IT WAS FURTHER REPORTED BUR WAS BROKEN THE MOMENT SURGEON PRESSED THE FOOTSWITCH.THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17273358 ↗
• MalfunctionApr 4, 2023Break; Break

  UPON FOLLOW UP BUR HEAD WAS LOOSE AND CAME FROM THE BODY BUT STILL ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16672410 ↗
• MalfunctionMar 13, 2023Break; Break

  IT WAS REPORTED THAT, WHEN SURGEON USED THE MICRODEBRIDER BUR AND WHILE DRILLING HALFWAY, THE BUR BROKE WITHIN THE PATIENT SINUS. HE WAS ABLE TO RETRIEVE ALL THE BROKEN PIECES FROM THE SINUS. PRIOR TO THE FAULT, HE DID NOT ENCOUNTER ANY UNUSUAL ENCOUNTERS (NO SOUND, NO WOBBLE OF THE BURS, NO HEATING UP OF HANDPIECE). THE PATIENT HAD LATENT TUBERCULOSIS. AN INTERVENTION WAS PERFORMED, THE SURGERY USES AN ENDOSCOPE. SURGEON WAS ABLE TO SEE AND CONFIRM WHAT WAS TAKEN OUT FROM THE SINUSES. THE BUR WAS REPLACED WITH ANOTHER SIMILAR PRODUCT AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16527883 ↗
• MalfunctionNov 16, 2022Break; Break

  A HEALTHCARE PROVIDER REPORTED THAT DURING SURGERY, THE FRONTAL SINUS HIGH SPEED BUR BROKE INTO 2 PIECES. THE BUR WAS BROKEN WHILE BEING USED ON A PATIENT. THE TIP OF THE BUR, INCLUDING THE SPIRAL PORTION OF THE TIP WAS BROKEN. THE DISTAL TIP WAS COMPLETELY DETACHED FROM THE DEVICE. THE PIECE WAS IN THE MAXILLARY SINUS AND WAS REMOVED WITH FORCEPS. THERE WAS NO ANY FRAGMENTS REMAIN IN THE PATIENT. THERE WAS NO ANY UNANTICIPATED MEDICAL INTERVENTIONS, PROCEDURES OR TREATMENTS PERFORMED OR GIVEN AT THE TIME OF THE EVENT TO REMOVE THE FRAGMENTS FROM THE PATIENT. THERE WAS NO BROKEN PARTS CONTAINED IN THE HANDPIECE OR IN THE OUTER SHAFT THAT PREVENTED THE FRAGMENTS FROM FALLING OUT AND CONTACTING THE PATIENT. THERE WAS NO PATIENT OR STAFF IMPACT ASSOCIATED WITH THIS DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15808190 ↗
• MalfunctionDec 14, 2021Break; Break

  ADDITIONAL INFORMATION RECEIVED STATED THE PROCEDURE BEING PERFORMED WAS FESS. THERE WAS A DELAY IN THE PROCEDURE HOWEVER, THE DURATION OF DELAY WAS NOT PROVIDED. THERE WAS NO DAMAGE TO THE PACKAGING OF THE BUR PRIOR TO USE. THE BURR WAS ASSEMBLED CORRECTLY. PROPER TECHNIQUE WAS USED TO DISMANTLE THE BURR FROM THE HANDPIECE. THE USER WANTED TO SWAP TO ANOTHER BURR. AT THAT TIME, AN ATTEMPT WAS MADE TO DISMANTLE THE BURR FROM THE HANDPIECE. THE OUTER SHAFT WAS DISMANTLED EASILY BUT THE INNER SHAFT RETAINED IN THE HANDPIECE. ONLY MANUAL FORCE(HAND) WAS USE BUT IT WAS UNSUCCESSFUL. A DECISION MADE TO STOP THE ATTEMPT AND SENT THE HANDPIECE FOR REPAIR. THE HANDPIECE WAS IN USE WITH ANOTHER BURR (PRIOR TO THE PROBLEMATIC BURR) WITH NO PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13002060 ↗
• MalfunctionJul 20, 2021Break; Break

  IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL THAT THE TIP OF DRILL BIT WAS BROKEN DURING SURGERY. THERE WAS NO BROKEN PIECE OF THE REPORTED PRODUCT THAT REMAINED INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED BY A BACK UP PRODUCT WITH NO DELAY. THERE WAS NO PATIENT IMPACT. UPON FOLLOW UP IT WAS REPORTED THAT THE BLADE BROKE WHILE BEING USED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12198035 ↗
• MalfunctionJul 1, 2020Break; Break

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA DISTRIBUTOR THAT AFTER 10 MINUTES OF USE THE INNER BLADE GOT FRACTURED. A NEW BLADE WAS USED TO COMPLETE THE FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). THERE WAS A 5 MINUTE DELAY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10216272 ↗
• InjuryMar 3, 2020Mechanical Jam; Mechanical Jam

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT DURING A SINUS SURGERY (FRONTAL SINUS APPROACH) A BUR WAS STUCK IN THE HANDPIECE AND THE HCP COULDN'T CHANGE IT SO THEY HAD TO STOP THE SURGERY AND PROGRAM ANOTHER SURGERY FOR THE PATIENT. THERE WAS NO PATIENT IMPACT. THE SURGERY WAS EXTENDED FOR 30 MINUTES.

  Patient problems: Oversedation

  MAUDE report 9778988 ↗
• MalfunctionFeb 20, 2020Break; Break

  A HEALTHCARE PROVIDER (HCP) REPORTED VIA DISTRIBUTOR THAT A DEVICE BUR WAS BROKEN DURING OPERATION AND THE BROKEN PART WAS STILL IN THE BLADE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9732540 ↗
• MalfunctionAug 6, 2018Break; Material Fragmentation; Material Fragmentation

  A CUSTOMER REPORTED THAT THE BUR TIP BROKE WITHIN THE FIRST MINUTE AFTER STARTING TO BE ROTATED AND AN IRON POWDER SCATTERED OVER THE SURGICAL FIELD. THE SECOND BUR WAS ATTACHED AND ROTATED, BUT THE TIP OF THE SECOND BUR BROKE AS WELL. IT WAS NOTED THAT THERE WAS NO PATIENT ASSOCIATED WITH THE EVENT. ADDITIONAL INFORMATION INDICATED THAT THE FIRST BUR'S FRAGMENT SCATTERED OVER THE SURGICAL FIELD, AND THEY WERE REMOVED BY CLEANING THE SURGICAL FIELD. THERE WERE NO PIECES THAT REMAINED IN THE PATIENT'S BODY. FOR THE 2ND BUR, THERE WAS NO FRAGMENT. THE BROKEN PIECE WAS PICKED UP BY FORCEPS. THERE WAS NO BROKEN PIECE/ FRAGMENT WHICH REMAINED IN THE PATIENT'S BODY. ALSO, THERE WAS NO PATIENT IMPACT. THE SITE HAD 2 BURS, SO THE SURGERY WAS COMPLETED WITH OTHER INSTRUMENTS SUCH AS FORCEPS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7755187 ↗
• MalfunctionApr 27, 2018Break; Material Separation; Break; Material Separation

  A CUSTOMER REPORTED VIA A MANUFACTURER REPRESENTATIVE (REP) THAT THE TIP OF THE BLADE BROKE OFF IN THE PATIENT'S NOSE. THE SURGEON WAS ABLE TO RETRIEVE THE PIECE. IT WAS NOTED THAT THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7468415 ↗
• MalfunctionApr 13, 2018Break; Break

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE TIP OF THE HI-SPEED BUR BROKE OFF. THERE WAS NO PATIENT IMPACT AS A RESULT OF THE DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7430486 ↗
• MalfunctionMar 28, 2018Material Fragmentation; Material Fragmentation

  THE PHYSICIAN REPORTED THAT THE HEAD OF THE BUR BROKE OFF DURING THE PROCEDURE. THE SURGEON RETRIEVED THE FRAGMENTS FROM THE SINUS; THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7376761 ↗
• MalfunctionDec 22, 2017Break; Break

  THE PHYSICIAN REPORTED THAT DURING ¿THE EARLY STEP¿ OF AN ESS (ENDOSCOPIC SINUS SURGERY), ¿THE BUR WAS BROKEN. A BACK-UP DEVICE WAS USED INSTEAD, AND THE PROCEDURE WAS COMPLETED WITH THE BACK-UP DEVICE.¿ THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7141626 ↗
• MalfunctionAug 28, 2017Break; Break

  THE SALES REPRESENTATIVE REPORTED THAT THE DOCTOR WAS INSERTING A HIGH SPEED RAD FRONTAL FINESSE BUR INTO AN M4 HANDPIECE WHEN THE DOCTOR PULLED ON THE FRONT AND A PIECE (TIP AND SPIRAL WRAP) OF THE BUR BECAME LOOSE. THE BUR WAS IMMEDIATELY TAKEN OUT THE M4 HANDPIECE AND OTHER BURS WERE USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6825120 ↗
• MalfunctionJun 8, 2017Material Fragmentation; Material Fragmentation

  THE FACILITY REPORTED THAT DURING A FESS, THE "FRONTAL BURR SUDDENLY BROKE AND THE TIP EJECTED DURING THE OPERATION (NOT IN THE PATIENT). TIP FLEW NEAR ANESTHETIC MACHINE." THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6623387 ↗
• MalfunctionMar 31, 2017Material Fragmentation; Material Fragmentation

  ADDITIONAL INFORMATION PROVIDED INDICATES THAT THE FRAGMENT WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. THERE WAS NO ADDITIONAL EQUIPMENT OR PROCEDURE REQUIRED TO RETRIEVAL THE FRAGMENT. AN ADDITIONAL (REPLACEMENT) BUR WAS USED TO COMPLETE THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6449410 ↗
• MalfunctionFeb 3, 2017Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THIS EVENT OCCURRED DURING A BARIATRIC (GASTRIC SLEEVE) PROCEDURE. THE USER ALSO CONFIRMED THAT NO PIECE(S) DETACHED FROM THE DEVICE AND FELL INTO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6300936 ↗