NA MA15-4DRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00845384004578), received between Dec 10, 2019 and Nov 20, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A TRANSSPHENOIDAL PROCEDURE, IT WAS DISCOVERED THAT THE CUTTER DEVICE FRACTURED DURING USE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. 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 20737744 ↗
• MalfunctionMar 7, 2021Break; Break

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BURR DEVICE WAS JAMMED INSIDE THE BEARING SLEEVE AND ATTACHMENT DEVICE. DURING THE ASSESSMENT IT WAS NOTED THAT IT WAS POSSIBLE TO REMOVE THE CUTTER AND BEARING SLEEVE FROM THE ATTACHMENT LOCKING MECHANISM. IT WAS FURTHER DETERMINED THAT THE CUTTER SHAFT WAS BENT CLOSE TO THE DIAMOND BALL AND AT ITS LOCKING GROOVE. IT WAS NOT POSSIBLE TO CONNECT THE DEVICE TO THE SERVICE CENTER'S EQUIPMENT DUE TO THE DENT AT THE END OF THE SHAFT. IT WAS FURTHER OBSERVED THAT THE DIAMOND BALL CARRIED RESIDUES, AND ALONG THE CUTTER SHAFT, THERE WERE SIGNS OF USAGE AND CORROSION DETECTED, WHICH MOST LIKELY RESULTED FROM REPROCESSING OF ALL THE THREE PARTS INTERLOCKED. IT WAS DETERMINED THAT THE CUTTER COULD NOT BE INSERTED AND WAS DAMAGED. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNDETERMINED MALFUNCTION WHILE BEING USED TOGETHER WITH THE ATTACHMENT AND BEARING SLEEVE 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 THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11426518 ↗
• MalfunctionDec 3, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED FROM (B)(6) THAT DURING A RESECTION OF A COMBINED LEVEL 5 BRAIN LESION OR SKULL BASE SURGICAL PROCEDURE, THE CUTTER DEVICE WAS SPLIT NEAR THE JUNCTION WITH SPHERICAL PART WHILE STARTING THE DRILLING AT THE ENDONASAL APPROACH. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR WHETHER A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS 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 2020. 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 10942268 ↗
• MalfunctionDec 10, 2019Material Fragmentation; Excessive Heating; Material Fragmentation; Excessive Heating

  THIS IS REPORT 1 OF 3 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING AN ENDOSCOPIC LUMBAR LAMINECTOMY MEPD MILD SURGICAL PROCEDURE FOR A LUMBAR SPINAL CANAL STENOSIS (ARTHROSCOPIC ABLATION FOR ARCH OF LUMBAR VERTEBRA) IT WAS OBSERVED THAT AFTER 3 TO 5 MINUTES OF CUTTING OUT BONE WITH A MINIMAL ACCESS DRIVER DEVICE, BEARING SLEEVE DEVICE, AND CUTTER DEVICE, THE HANDLE OF THE DEVICE HAD BECOME QUITE HEATED, AND THE BAR OF THE CUTTING BURR DEVICE IMMEDIATELY BROKE OFF. IT WAS REPORTED THAT THE DEVICE DROVE AT 80,000 ROTATIONS PER MINUTE (RPM) DURING THE ABLATION. IT WAS REPORTED THAT THERE WAS A FIVE-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE AVAILABLE FOR USE. THERE WAS 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9443923 ↗

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-2009-2017 · Oct 6, 2016 · Terminated
  Minimal Access Attachment Product Usage: Pneumatic system
• Z-2011-2017 · Oct 6, 2016 · Terminated
  Minimal Access Straight Driver Product Usage: Pneumatic system
• Z-2006-2017 · Oct 6, 2016 · Terminated
  Bearing Sleeve, 15CM Straight Product Usage: Pneumatic system
• Z-2004-2017 · Oct 6, 2016 · Terminated
  Bearing Sleeve, 10CM Straight Product Usage: Pneumatic system
• Z-2003-2017 · Oct 6, 2016 · Terminated
  Bearing Sleeve, 10CM Curved 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-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-0756-2014 · Mar 29, 2012 · Terminated
  MCA5-1SB - 1MM 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 cochl
• Z-0768-2014 · Mar 29, 2012 · Terminated
  MCA7-2SB - 2MM 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-0761-2014 · Mar 29, 2012 · Terminated
  MCA7-06SD - 0.6MM 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-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-0753-2014 · Mar 29, 2012 · Terminated
  MCA5-08SD - 0.8MM 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-0751-2014 · Mar 29, 2012 · Terminated
  MCA5-06SD - 0.6MM 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-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

…and 16 more.