NA MA15-8NRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00845384004592), received between Jun 17, 2019 and Jan 22, 2021 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE TIP OF THE CUTTER DEVICE BROKE OFF WHILE IN USE ON THE PATIENT. IT WAS REPORTED THAT THE BROKEN PIECE WAS DETAINED AND THE SURGICAL SITE WAS INSPECTED WITH A MICROSCOPE AND NO PARTS OF THE DEVICE REMAINED INSIDE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE PROCEDURE DUE TO THE EVENT. IT WAS REPORTED THAT THERE WAS AN UNSPECIFIED SPARE DEVICE AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11214422 ↗
• MalfunctionJan 7, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED MINIMAL INVASIVE SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CUTTER DEVICE BROKE OFF. IT WAS REPORTED THAT THE USER WAS ABLE TO RETRIEVE THE BROKEN PIECE AND CONTINUE THE PROCEDURE. IT WAS REPORTED THAT A THERE WAS A FIVE MINUTE DELAY TO THE SURGICAL PROCEDURE AND A SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2019. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9558552 ↗
• MalfunctionNov 11, 2019Fracture; Fracture

  IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CUTTER DEVICE BROKE WHILE THE USER WAS USING IT IN THE INCISION SITE. IT WAS REPORTED THAT THE WHOLE PIECE WAS RETRIEVED. IT WAS REPORTED THAT AFTER THE CASE, THE USER CHECKED THE DEVICE AND FOUND THAT IT WAS BROKEN. IT WAS FURTHER REPORTED THAT IT DID NOT APPEAR AS THOUGH X-RAYS, ANTIBIOTICS OR IRRIGATION WAS NECESSARY. 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 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 9305795 ↗
• MalfunctionOct 21, 2019Fracture; Fracture

  IT WAS REPORTED FROM CANADA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE SPINE IT WAS OBSERVED THAT THE TIP OF THE BURR DEVICE BROKE OFF DURING USE AFTER FIVE MINUTES. IT WAS REPORTED THAT THE USER WAS ABLE TO RETRIEVE THE TIP OF THE DEVICE FROM THE PATIENT. IT WAS NOT REPORTED IF THERE WAS A 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 9215789 ↗
• MalfunctionSep 19, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE BURR DEVICE BROKE OFF IN THE ATTACHMENT DEVICE. ACCORDING TO THE REPORT, THE BURR DEVICE WAS NOT BEING SECURED BY THE ATTACHMENT DEVICE; AND THAT THE ATTACHMENT DEVICE MAY HAVE SOME OF THE BROKEN BURR DEVICE STUCK INSIDE. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A DELAY TO A PLANNED PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE AVAILABLE FOR USE. 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9086264 ↗
• MalfunctionJun 20, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE DISCECTOMY (MIS) SURGICAL PROCEDURE OF THE SPINE, IT WAS OBSERVED THAT THE DRILL BIT HEAD ON THE CUTTER DEVICE SEPARATED FROM THE STEM INTO TWO SEPARATE PIECES, WHILE BEING USED WITH A BEARING SLEEVE DEVICE. IT WAS REPORTED THAT THE USER WAS ABLE TO RECOVER BOTH PIECES AND ENSURED THAT NOTHING WAS LEFT IN THE PATIENT OR IN THE SURGICAL FIELD BY EXAMINING UNDER THE MICROSCOPE. IT WAS ALSO REPORTED THAT THE TWO PIECES WERE RETAINED. IT WAS REPORTED THAT THERE WAS A FIVE MINUTE DELAY IN THE SURGICAL PROCEDURE. IT WAS REPORTED THAT THE PROCEDURE WAS ABLE TO BE COMPLETED WITHOUT FURTHER USE OF THE DRILL BIT. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED ON 2019. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 8715747 ↗
• MalfunctionJun 18, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE DISCECTOMY SURGICAL PROCEDURE OF THE SPINE, IT WAS OBSERVED THAT THE DRILL BIT HEAD ON THE CUTTER DEVICE SEPARATED FROM THE STEM INTO TWO SEPARATE PIECES, WHILE BEING USED WITH A BEARING SLEEVE DEVICE. IT WAS REPORTED THAT THE USER WAS ABLE TO RECOVER BOTH PIECES AND ENSURE THAT NOTHING WAS LEFT IN THE PATIENT OR IN THE SURGICAL FIELD BY EXAMINING UNDER THE MICROSCOPE. IT WAS ALSO REPORTED THAT THE TWO PIECES WERE RETAINED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. IT WAS REPORTED THAT THE PROCEDURE WAS ABLE TO BE COMPLETED WITHOUT FURTHER USE OF THE DRILL BIT. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2019. 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 8707029 ↗
• MalfunctionJun 17, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE DISCECTOMY SURGICAL PROCEDURE OF THE SPINE, IT WAS OBSERVED THAT THE DRILL BIT HEAD ON THE CUTTER DEVICE SEPARATED FROM THE STEM INTO TWO SEPARATE PIECES, WHILE BEING USED WITH A BEARING SLEEVE DEVICE. IT WAS REPORTED THAT THE USER WAS ABLE TO RECOVER BOTH PIECES AND ENSURE THAT NOTHING WAS LEFT IN THE PATIENT OR IN THE SURGICAL FIELD BY EXAMINING UNDER THE MICROSCOPE. IT WAS ALSO REPORTED THAT THE TWO PIECES WERE RETAINED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. IT WAS REPORTED THAT THE PROCEDURE WAS ABLE TO BE COMPLETED WITHOUT FURTHER USE OF THE DRILL BIT. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO 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: Foreign Body In Patient

  MAUDE report 8703675 ↗

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-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-2009-2017 · Oct 6, 2016 · Terminated
  Minimal Access Attachment Product Usage: Pneumatic system
• Z-2005-2017 · Oct 6, 2016 · Terminated
  Bearing Sleeve, 15CM Curved Product Usage: Pneumatic system
• Z-2004-2017 · Oct 6, 2016 · Terminated
  Bearing Sleeve, 10CM Straight 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-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-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
• 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-0765-2014 · Mar 29, 2012 · Terminated
  MCA7-15SD - 1.5MM 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-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-0767-2014 · Mar 29, 2012 · Terminated
  MCA7-1SD - 1MM 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
• Z-0752-2014 · Mar 29, 2012 · Terminated
  MCA5-07SD - 0.7MM 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-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

…and 16 more.