NA MA19-4DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00845384011903), received between Feb 20, 2019 and Feb 20, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2019Fracture; Fracture

  IT WAS REPORTED FROM FRANCE THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE CUTTER DEVICE BROKE IN THE PATIENT DURING USE. IT WAS REPORTED THAT THE BROKEN PART WAS REMOVED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WAS PATIENT INVOLVEMENT REPORTED. 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8353534 ↗

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-2005-2017 · Oct 6, 2016 · Terminated
  Bearing Sleeve, 15CM Curved Product Usage: Pneumatic system
• Z-2006-2017 · Oct 6, 2016 · Terminated
  Bearing Sleeve, 15CM Straight Product Usage: Pneumatic system
• Z-2009-2017 · Oct 6, 2016 · Terminated
  Minimal Access Attachment 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-2011-2017 · Oct 6, 2016 · Terminated
  Minimal Access Straight Driver 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-0760-2014 · Mar 29, 2012 · Terminated
  MCA7-05SD - 0.5MM 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-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-0757-2014 · Mar 29, 2012 · Terminated
  MCA5-1SD - 1MM 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 coch
• Z-0715-2014 · Mar 29, 2012 · Terminated
  Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures
• Z-0758-2014 · Mar 29, 2012 · Terminated
  MCA5-2SB - 2MM 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-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-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

…and 16 more.