NA 1608002131Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04546540030528), received between Aug 15, 2019 and Jan 21, 2025 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD INSUFFICIENT INFORMATION RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21200273 ↗
• MalfunctionFeb 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WAS A FIFTEEN MINUTE DELAY WHICH THE SURGEON IRRIGATED AND USED SUCTION TO REMOVE THE BROKEN FRAGMENT FROM THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16408274 ↗
• MalfunctionFeb 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE DRILL BIT BROKE, AN X-RAY WAS PERFORMED TO LOCATE THE BROKEN TIP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY A DELAY OF FIVE MINUTES; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16369118 ↗
• InjuryFeb 1, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY ON PROXIMAL FINGER, THE TIP OF THE DRILL BIT BROKE. IT WAS ALSO REPORTED THAT THE SURGEON MADE MULTIPLE ATTEMPTS TO RETRIEVE THE BROKEN TIP BUT WAS UNSUCCESSFUL. IT WAS FURTHER REPORTED THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16278008 ↗
• MalfunctionJan 12, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BUR BROKE AT THE TIP. THE TIP WAS IMPLANTED IN THE PATIENTS BONE. ATTEMPTS WERE MADE TO REMOVE THE BUR TIP FROM THE BONE, BUT RETRIEVAL WOULD HAVE RESULTED IN DAMAGE TO THE BONE. THEREFORE, THE TIP REMAINED IMPLANTED IN THE BONE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY TO THE PROCEDURE; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16146892 ↗
• MalfunctionNov 10, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE BUR BROKE AT THE CUTTING END DURING A SURGICAL PROCEDURE. IT WAS ALSO REPORTED THAT THE TIP OF THE BUR REMAINS IN THE PATIENT. IT WAS FURTHER REPORTED THAT THERE WERE NO DELAYS AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15769269 ↗
• MalfunctionNov 23, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THE TIP OF THE BUR BROKE OFF. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WAS A DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10885116 ↗
• MalfunctionNov 5, 2020Break; Detachment of Device or Device Component

  PER OPERATIVE NOTE:...A STARTING AWL WAS PLACED AT THE MIDDLE PHALANX IN THE CENTRAL ASPECT SLIGHTLY DORSAL. THERE WAS HARD, THICK AND CORTICAL BONE. THEREFORE, A SWANSON BUR WAS USED. A HIGH-SPEED BUR TO BUR WAS USED TO CREATE A STARTING POINT. THE TIP OF THE BURR DID BREAK OFF DOWN THE MEDULLARY CANAL OF THE MIDDLE PHALANX AND WAS NOT RETRIEVABLE. AFTER CREATING A STARTING POINT, THE AWL WAS USED IN ORDER TO CREATE ROOM FOR OUR BROACH. WE THEN SEQUENTIALLY BROACHED UP TO A SIZE 20 TO MATCH OUR PROXIMAL PHALANX. THE BROACH SEATED NICELY, AND IT ALSO FIT TIGHTLY DOWN THE MEDULLARY CANAL OF THE MIDDLE PHALANX CORTEX. THIS WAS CHECKED UNDER FLUOROSCOPY WHILE PERFORMING THE BROACHING. THE BROACH WAS CENTRAL DOWN THE MEDULLARY CANAL, AND IT WAS A TIGHT FIT. IT WAS FELT THAT THIS WAS APPROPRIATE SIZE FOR OUR ARTHROPLASTY. THE AREA WAS THEN COPIOUSLY IRRIGATED, OUR OUTER GLOVES WERE CHANGED, AND ALL TOWEL LINT REMOVED FROM THE HAND TABLE. THE AREA WAS ONCE AGAIN IRRIGATED...

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10791974 ↗
• MalfunctionFeb 25, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE OFF IN THE PATIENTS INTERPHALANGEAL JOINT. IT WAS ALSO REPORTED THAT THE BUR FRAGMENT WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. IT WAS FURTHER REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9751375 ↗
• MalfunctionOct 18, 2019Break; Break

  IT WAS REPORTED VIA MEDWATCH MW5089616 THAT THE BLADE BROKE DURING A SURGICAL PROCEDURE ON A FINGER. IT WAS FURTHER REPORTED THAT THE SURGEON WAS NOT ABLE TO RETRIEVE THE PIECE. IT WAS ALSO REPORTED THAT THE SURGEON TRIED FOR 30 MINUTES TO REMOVE IT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9208568 ↗
• InjuryAug 15, 2019Break; Break

  IT WAS REPORTED THAT DURING A PROXIMAL INTERPHALANGEAL (PIP) JOINT SURGICAL PROCEDURE, THE TIP OF THE BUR BROKE. IT WAS ALSO REPORTED THAT THE BROKEN TIP WAS EMBEDDED IN THE BONE, ATTEMPTS WERE MADE TO REMOVE THE TIP, BUT IT COULD NOT BE FOUND. IT WAS FURTHER REPORTED THAT THERE WERE NO DELAYS AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8898338 ↗