NA MA15-8NSRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00845384004615), received between May 20, 2018 and May 28, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

31 other recalls cover devices cleared under the same FDA submission (K042783); they may or may not involve this specific model.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE 3 MM FLUTED MATCHSTICK DEVICE WAS BROKEN WHILE IN USE WITH THE MINIMAL ACCESS DRIVER AND WAS RECEIVED STUCK IN IT. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT DEVICE FAILED VISUAL INSPECTION BECAUSE THE TIP OF THE CUTTER DEVICE WAS BROKEN OFF, IT WAS CUT OFF TO REMOVE THE DEVICE FROM THE MINIMAL ACCESS DRIVER DEVICE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22099927 ↗
• MalfunctionDec 4, 2023Material Fragmentation; Separation Problem; Material Fragmentation; Separation Problem

  IT WAS REPORTED BY SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE TIP OF THE DRILL BIT DEVICE HAD BROKEN OFF. IT WAS FURTHER OBSERVED THAT THE DRILL BIT WAS STUCK INSIDE THE ATTACHMENT DEVICE AND HAD TO BE CUT TO REMOVE IT. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED VISUAL INSPECTION BECAUSE THE DEVICE TIP HAD BROKEN OFF. IT WAS NOTED IN THE SERVICE ORDER THAT THE ATTACHMENT DEVICE HAD THE BEARING SLEEVE AND THE TIP OF THE CUTTER DEVICE STUCK INSIDE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18257452 ↗
• MalfunctionMar 4, 2022Material Fragmentation; Separation Problem; Material Fragmentation; Separation Problem

  IT WAS REPORTED THAT DURING TESTING, IT WAS DISCOVERED THAT THE ATTACHMENT DEVICE HAD ¿STICKY BURRS¿. IT WAS FURTHER REPORTED THAT THE ATTACHMENT CAME BACK WITH A CUTTER FRAGMENT STUCK IN IT AND NOTHING ELSE WAS VISIBLE. THE EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13666283 ↗
• MalfunctionNov 4, 2019Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CUTTER DEVICE BECAME STUCK INSIDE OF THE ATTACHMENT DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE CUTTER DEVICE WAS BROKEN OFF BELOW THE LASER MARKING AND STUCK INSIDE OF THE ATTACHMENT DEVICE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9275655 ↗
• MalfunctionFeb 19, 2019Fracture; Fracture

  IT WAS REPORTED FROM (B)(6) THAT DURING EQUIPMENT INSPECTION IT WAS OBSERVED THAT THE CUTTER DEVICE COULD NOT BE INSERTED INTO THE ATTACHMENT DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT A PIECE OF BROKEN CUTTER WAS STUCK INSIDE OF THE ATTACHMENT DEVICE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2018. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8349784 ↗
• MalfunctionDec 6, 2018Fracture; Fracture

  IT WAS REPORTED THAT THE BURR STUCK WAS STUCK IN THE ATTACHMENT DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE BURR DEVICE WAS FRACTURED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8140056 ↗
• MalfunctionMay 20, 2018Fracture; Fracture

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE BURR DEVICE SNAPPED. IT WAS REPORTED THAT THE DEVICE WAS BEING USED WITH A BEARING SLEEVE DEVICE. IT WAS NOT REPORTED IF THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE OR WHETHER A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7528659 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042783. One submission often covers many models, so check the product and lot details in each record.

• Z-2011-2017 · Oct 6, 2016 · Terminated
  Minimal Access Straight Driver Product Usage: Pneumatic system
• Z-2009-2017 · Oct 6, 2016 · Terminated
  Minimal Access Attachment Product Usage: Pneumatic system
• Z-2007-2017 · Oct 6, 2016 · Terminated
  Bearing Sleeve, 15CM Straight Taper Product Usage: Pneumatic system
• Z-2005-2017 · Oct 6, 2016 · Terminated
  Bearing Sleeve, 15CM Curved Product Usage: Pneumatic system
• Z-2003-2017 · Oct 6, 2016 · Terminated
  Bearing Sleeve, 10CM Curved Product Usage: Pneumatic system
• Z-2004-2017 · Oct 6, 2016 · Terminated
  Bearing Sleeve, 10CM Straight Product Usage: Pneumatic system
• Z-2006-2017 · Oct 6, 2016 · Terminated
  Bearing Sleeve, 15CM Straight Product Usage: Pneumatic system
• Z-0708-2014 · Oct 26, 2012 · Terminated
  Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments) MCA - MICRO CURVED ATTACHMENT, MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM, M
• Z-0763-2014 · Mar 29, 2012 · Terminated
  MCA7-08SD - 0.8MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as c
• Z-0762-2014 · Mar 29, 2012 · Terminated
  MCA7-07SD - 0.7MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as c
• Z-0766-2014 · Mar 29, 2012 · Terminated
  MCA7-1SB - 1MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochl
• Z-0749-2014 · Mar 29, 2012 · Terminated
  Micro Curved Attachment (MCA) Cutting Burr, DFU 18-0001. All lots are included in recall. Part Number MCA Intended for use in cutting and shaping delicate bone material, primaril
• Z-0754-2014 · Mar 29, 2012 · Terminated
  MCA5-15SB - 1.5MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as co
• Z-0755-2014 · Mar 29, 2012 · Terminated
  MCA5-15SD - 1.5MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as c
• Z-0769-2014 · Mar 29, 2012 · Terminated
  MCA7-2SD - 2MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as coch

…and 16 more.