Rotatable Fusion® 1884380EMRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00643169209367), received between Mar 23, 2017 and Sep 1, 2021 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2021Vibration; Vibration

  A MANUFACTURER REPRESENTATIVE REPORTED THAT THE BLADE HAD A SEVERE WOBBLE TO IT WHEN THEY TRIED TO USE IT DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). THEY TRIED RE-SEATING THE BLADE IN THE HANDPIECE BUT IT STILL WOBBLED AND HAD TOO MUCH MOVEMENT TO BE USED EFFECTIVELY. THE MANUFACTURER REPRESENTATIVE VISUALLY INSPECTED THE BLADE AND IT DID NOT APPEAR TO BE BROKEN. THEY OPENED A NEW BLADE AND IT WORKED WITHOUT ISSUE. THERE WAS NO DELAY IN THE PROCEDURE AS A RESULT OF THIS EVENT. THE DEVICE WAS USED ON THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12407025 ↗
• MalfunctionMar 20, 2020Break; Break

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE SURGEON BROKE THE BLADE. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9858290 ↗
• MalfunctionNov 28, 2019Material Separation; Material Separation

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE BLADE BROKE WHILE ENGAGING THE ETHMOID BONE. TRIED ANOTHER AND BOTH BLADES BROKE WHEN ATTEMPTING THE SAME ENGAGEMENT OF ETHMOID BONE DURING THE PROCEDURE FOR FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) WITH ETHMOIDECTOMY. THE PROCEDURE WAS COMPLETED USING BACK-UP PRODUCT. THERE WERE NO FRAGMENTS THAT REMAINED INSIDE THE PATIENT'S BODY. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED THERE ARE FRAGMENTS AND WAS RETURNED WITH THE BLADE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9389965 ↗
• MalfunctionOct 1, 2019Material Separation; Material Separation

  A HEALTH CARE PROVIDER REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE BLADE FAIL DURING A CASE, IT FELL APART AT THE BEGINNING OF THE SURGERY. IT LOOKED LIKE IT SHEARED OFF ABOUT 1 INCH DOWN ON SHAFT. THE PROCEDURE WAS DELAYED FOR LESS THAN 5 MINUTES. HCP GOT A NEW BLADE OFF THE SHELF. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9140022 ↗
• MalfunctionSep 13, 2019Break; Break

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE BLADE PERFORMED AS EXPECTED. THE POSITION THAT WAS USED IN THE STRAIGHT SHAVER BLADE WAS TO MOVE OR LATERALIZED ANATOMY. WHEN IT WAS NOT INTENDED TO DO AND AS WHEN THEY WERE MOVING OR LATERALIZING ANATOMY, THE BLADE BROKE. THE BLADE WAS THEN PULLED OUT FROM THE FIELD AND A NEW ONE WAS USED. THE TURN OVER WAS ABRUPTLY 3 MINS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9027258 ↗
• MalfunctionJul 22, 2019Vibration; Vibration

  IT WAS CONFIRMED THAT THIS DEVICE WAS THE ONE THAT WOBBLED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8811734 ↗
• MalfunctionJul 22, 2019Vibration; Physical Resistance/Sticking; Vibration; Physical Resistance/Sticking

  UPON FOLLOW UP IT WAS CONFIRMED THAT THE DEVICE ALLEGATION WAS STOPPED RUNNING ONLY. THIS DEVICE WAS NOT WOBBLING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8811152 ↗
• MalfunctionMay 2, 2019Material Separation; Use of Device Problem; Material Separation; Use of Device Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE BLADE WAS SNAPPED IN HALF. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8573427 ↗
• MalfunctionOct 30, 2018Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE HUB OF THE BLADE WHERE THE WIRE WAS ATTACHED DISENGAGED FROM THE BLADE DURING THE FUNCTIONAL ENDOSCOPIC SINUS SURGERY. THEY WERE ABLE TO QUICKLY IDENTIFY THE PROBLEM AND OPENED UP A NEW BLADE. THERE WAS NO PATIENT IMPACT AND ONLY A DELAY OF TWO MINUTES WHILE THE NURSE OPENED A NEW ONE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8018373 ↗
• MalfunctionAug 17, 2018Material Separation; Fitting Problem; Material Separation; Fitting Problem

  A HEALTHCARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE HUB OF THE BLADE THAT HOLDS THE NAVIGATION PIECE WAS LOOSE AND CAME APART DURING SETUP FOR AN ENDOSCOPIC SINUS SURGERY PROCEDURE. A BACK UP DEVICE WAS USED. THERE WAS NO DELAY WITH THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7795046 ↗
• MalfunctionMar 23, 2017Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING FOUR SEPARATE CASES, THE ¿TEETH¿ BROKE OFF THE BLADE AND INTO THE PATIENT. ALL PARTS WERE RETRIEVED. EACH CASE WILL BE REPORTED SEPARATELY. THIS REPORT IS FOR CASE 4 OF 4. (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 6429772 ↗
• MalfunctionMar 23, 2017Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING FOUR SEPARATE CASES, THE ¿TEETH¿ BROKE OFF THE BLADE AND INTO THE PATIENT. ALL PARTS WERE RETRIEVED. EACH CASE WILL BE REPORTED SEPARATELY. THIS REPORT IS FOR CASE 3 OF 4. MEDTRONIC INTERNAL REFERENCE NUMBERS: (B)(4) - 1 OF 4, (B)(4) - 2 OF 4, (B)(4) - 3 OF 4, (B)(4) - 4 OF 4.

  Patient problems: Foreign Body In Patient

  MAUDE report 6429765 ↗
• MalfunctionMar 23, 2017Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING FOUR SEPARATE CASES, THE ¿TEETH¿ BROKE OFF THE BLADE AND INTO THE PATIENT. ALL PARTS WERE RETRIEVED. EACH CASE WILL BE REPORTED SEPARATELY. THIS REPORT IS FOR CASE 1 OF 4. MEDTRONIC INTERNAL REFERENCE NUMBERS: (B)(4) - 1 OF 4, (B)(4) - 2 OF 4, (B)(4) - 3 OF 4, (B)(4) - 4 OF 4.

  Patient problems: Foreign Body In Patient

  MAUDE report 6429753 ↗
• MalfunctionMar 23, 2017Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING FOUR SEPARATE CASES, THE ¿TEETH¿ BROKE OFF THE BLADE AND INTO THE PATIENT. ALL PARTS WERE RETRIEVED. EACH CASE WILL BE REPORTED SEPARATELY. THIS REPORT IS FOR CASE 2 OF 4. MEDTRONIC INTERNAL REFERENCE NUMBERS: (B)(4) - 1 OF 4, (B)(4) - 2 OF 4. (B)(4) - 3 OF 4, (B)(4) - 4 OF 4.

  Patient problems: Foreign Body In Patient

  MAUDE report 6429735 ↗