ENT MR8 1847ATTSVRecalls & reported problems
Medtronic Powered Surgical Solutions · ATTACHMENT 1847ATTSV ENTMR8 STRAIGHT VAR · Class 2
Quick summary
This Medtronic ENT MR8 attachment for surgical drills has 88 adverse event reports, with no deaths and no injuries. Reports mostly describe the attachment heating up, parts such as bearings coming loose, and vibration. No recalls name this device. Report volume rose sharply, with 73 in the past 12 months compared with 13 the year before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 89
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 00763000356989), received between Aug 24, 2024 and Sep 17, 2026 — classified as 89 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- No Apparent Adverse Event38
- Detachment of Device or Device Component19
- Overheating of Device12
- Vibration12
- Naturally Worn9
- Difficult to Insert7
- Noise, Audible4
- Difficult to Remove2
Patient problems
- No Clinical Signs, Symptoms or Conditions87
- Insufficient Information3
Recent adverse event reports
The 25 most recent of 89 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Naturally Worn
It was reported that attachment is broken. At the time of report there was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803824 ↗MalfunctionSep 17, 2026Overheating of Device
Medtronic received information regarding a repair request, and no alleged product deficiencies were reported. There was no patient i nvolvement or complications as a result of the event. Additional information received that the alleged issue was overheating and the event occurred post-operatively. Additional information received on evaluation stated that the distal bearing was detached madethis event reportable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50797810 ↗MalfunctionSep 15, 2026Loss of Power
It was reported that the device was not rotating properly during testing. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775115 ↗MalfunctionAug 31, 2026Overheating of Device; Physical Resistance/Sticking
It was reported that the attachment is heating up and not working. It was reported that there was no patient impact. Additional information received stating that the distal bearing is detached.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50517979 ↗MalfunctionAug 31, 2026Naturally Worn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50515457 ↗MalfunctionAug 13, 2026Overheating of Device; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50232228 ↗MalfunctionAug 11, 2026No Apparent Adverse Event
.It was reported that the customer had dissatisfaction with the product. At the time of report there was no patient impact. Additional information received that loose bearings were observed during evaluation .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50206443 ↗MalfunctionAug 9, 2026Vibration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50188824 ↗MalfunctionAug 8, 2026Overheating of Device; Vibration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50185854 ↗MalfunctionAug 8, 2026No Apparent Adverse Event
It was reported that the customer had a dissatisfaction with the product and the defect was unknown. There was no patient involvement. Additional information was received stating bearing detachment was found during evaluation.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50185106 ↗MalfunctionAug 7, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50172754 ↗MalfunctionAug 7, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50172130 ↗MalfunctionAug 7, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50171450 ↗MalfunctionAug 7, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50170391 ↗MalfunctionAug 7, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50169728 ↗MalfunctionAug 7, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50169636 ↗MalfunctionAug 7, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50169523 ↗MalfunctionAug 6, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50161101 ↗MalfunctionAug 6, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50160112 ↗MalfunctionAug 6, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50156064 ↗MalfunctionAug 6, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50155590 ↗MalfunctionAug 6, 2026No Apparent Adverse Event
Medtronic received information regarding a repair request and no alleged product deficiencies were reported. It was reported that there was no patient involvement. Additional information was received stating that detached bearings were found during evaluation.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50151908 ↗MalfunctionAug 5, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50139333 ↗MalfunctionAug 5, 2026Loss of Power
It was reported that the device did not turn on prior to use. It was reported that there was no patient involvement. Additional information was received stating that bearing detachment were found during evaluation.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50137803 ↗MalfunctionAug 5, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50137801 ↗
Other DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE devices
- RemB 6400034000Stryker Corporation · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1,618 reports
- NA XMAXAnspach Effort, The · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1,225 reports
- NA EG1ASynthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE859 reports
- NA CRANI-ASynthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1 recall772 reports
- NA 5450400000Stryker Corporation · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE775 reports
- NA 05.001.010Synthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE770 reports
- RemB 6400015000Stryker Corporation · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE603 reports
- NA QD11Synthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE580 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.