NA A-CRN-G1Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00845384012603), received between Oct 15, 2018 and Jan 27, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Separation Problem” (5 reports).

39 other recalls cover devices cleared under the same FDA submission (K113476); 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Material Fragmentation; Separation Problem

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE 1.85MM X 16 MM FRTR, CRNA DEVICE BROKE INTO TWO PIECES (FRACTURED). IT WAS REPORTED IN THE SERVICE ORDER THAT THE USER WAS UNABLE TO REMOVE THE CUTTER DEVICE. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24190821 ↗
• MalfunctionJan 5, 2026Material Fragmentation

  IT WAS REPORTED THAT AT THE END OF AN UNKNOWN SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE 1.85MM X 16 MM FRTR,CRNA DEVICE, WHEN THE SURGEON CHECKED THE ATTACHMENT HE FOUND THAT THE BAR HAD BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23958333 ↗
• MalfunctionAug 1, 2023Material Fragmentation; Separation Problem; Material Fragmentation; Separation Problem

  IT WAS REPORTED THAT THE CRANIOTOME DEVICE DID NOT UNLOCK FROM THE MOTOR DEVICE AND THE BLADE SHAFT WAS STUCK INSIDE THE CRANIOTOME DEVICE AND WOULD NOT COME OFF. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS OBSERVED THAT THE BURR DEVICE WAS INSIDE THE CRANIOTOME DEVICE. IT WAS REPORTED THE DEVICE WAS TAKEN APART AND THAT MEDICAL DEPOSIT AND SOAP RESIDUE WERE OBSERVED IN THE BURR LOCK ASSEMBLY. IT WAS REPORTED THAT THE DEVICE FAILED VISUAL INSPECTION DUE TO THE BROKEN PART. IT WAS NOTED THAT A FULL ASSESSMENT OF THE BURR DEVICE WAS NOT PERFORMED SINCE ONLY A FRACTION OF IT WAS RECEIVED. 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 A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17434959 ↗
• MalfunctionMay 18, 2023Fracture; Separation Problem; Fracture; Separation Problem

  IT WAS REPORTED THAT THE CRANITOME DEVICE CUTTER HAD SEIZED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE CUTTER HAD FRACTURED INTO TWO PIECES, IT WAS DIFFICULT TO REMOVE THE CUTTER DEVICE AND WAS CORRODED. THE DEVICE ALSO FAILED PRETEST FOR VISUAL ASSESSMENT. 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. THE DATE OF EVENT WAS UNKNOWN. 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 16953331 ↗
• MalfunctionDec 11, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED FROM CANADA THAT WHILE CUTTING THE SKULL FLAP A CRANIOTOMY SURGICAL PROCEDURE, IT WAS DISCOVERED THE BURR BROKE AND A PIECE OF THE BURR GOT STUCK IN THE BONE, WHICH WAS LATER RETRIEVED. IT WAS REPORTED THAT THERE WAS A FIVE MINUTE DELAY TO THE SURGICAL PROCEDURE AND A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 15956248 ↗
• MalfunctionMar 8, 2022Dull, Blunt; Separation Problem; Dull, Blunt; Separation Problem

  IT WAS REPORTED THAT DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE ROUTER OF THE CUTTER DEVICE WAS GENERALLY WORN, DIRTY AND NOT CLEANED PROPERLY. IT WAS NOTED IN THE SERVICE ORDER THAT THE HANDPIECE DEVICE WAS OVERHEATING AND THE CUTTER DEVICE WAS UNABLE TO BE DETACHED. 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 13688145 ↗
• MalfunctionMay 19, 2021Break; Break

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BURR DEVICE SHOWED CLEAR SIGNS OF USE AND BROKEN CUTTING ETCHES AND THE INTERIOR SURFACE WAS CORRODED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS FOUND TO BE ¿SPOILED¿ POST-SURGERY WITH A CRANIOTOME 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 THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2021. 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 11852065 ↗
• MalfunctionDec 14, 2020Fracture; Separation Problem; Fracture; Separation Problem

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS OBSERVED THAT THE CUTTER DEVICE BROKE WHILE TRYING TO REMOVE IT FROM THE ATTACHMENT DEVICE. IT WAS REPORTED THAT THE CUTTING DEVICE WAS RECEIVED STUCK IN THE CRANIOTOME ATTACHMENT DEVICE. IT WAS REPORTED THAT THE CUTTER WAS FULLY CORRODED, AND DEBRIS WAS ALL OVER THE CUTTING TOOL. IT WAS REPORTED IN THE SERVICE ORDER THAT THE CRANIOTOME HAD BEARING DAMAGE AND THE BURR DEVICE WAS UNABLE TO BE DETACHED. 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 11003905 ↗
• MalfunctionAug 29, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CUTTER DEVICE WAS BLOCKED INSIDE THE CRANIOTOME DEVICE. IT WAS FURTHER DETERMINED THAT IT WAS DIFFICULT TO REMOVE THE CUTTER FROM THE ATTACHMENT. IT WAS OBSERVED THAT THE CUTTER WAS HEAVILY WORN OUT AND DAMAGED AND WAS NOT USABLE ANYMORE. IT WAS NOTED IN THE SERVICE ORDER THAT WHILE CLEANING THE CRANIOTOME DEVICE AFTER A PROCEDURE, IT WAS DISCOVERED THAT THE CUTTER DEVICE WAS NOT COMING OUT OF THE CRANIOTOME DEVICE (CUTTER WAS NOT DISENGAGING FROM THE ATTACHMENT). 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 AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8945260 ↗
• MalfunctionOct 29, 2018Device Damaged by Another Device; Device Damaged by Another Device

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE CRANIOTOME DEVICE WHILE BEING USED WITH THE CUTTER DEVICE WAS HEATING UP AND CREATING BLACK LINES ON THE CUTTING BURR. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED USING THE SAME DEVICES. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER IT WAS NOTED THAT THE EVENT 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 8013729 ↗
• MalfunctionOct 15, 2018Fracture; Fracture

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT: IT WAS REPORTED THAT THE CUTTER DEVICE WAS STUCK IN THE SHAFT OF THE CRANIOTOME DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE CUTTER DEVICE COULD NOT BE REMOVED FROM THE CRANIOTOME DEVICE DUE TO WORN OUT BEARINGS AND THE NEURO-TIP LEG HAD BEEN DRILLED INTO. IT WAS FURTHER DETERMINED THAT THE CUTTER WAS FRACTURED. 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. THE EXACT DATE OF THIS EVENT WAS UNKNOWN. 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 7966480 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113476. One submission often covers many models, so check the product and lot details in each record.

• Z-2839-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and cranium.
• Z-2840-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M; For cutting and shaping bone including spine and cranium.
• Z-2837-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spine and cranium.
• Z-2838-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M; For cutting and shaping bone including spine and cranium.
• Z-2283-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Drum, Side Cut only, 6MM x 14MM REF L-6DRC-G1 Cutting shaping bone including spine and cranium.
• Z-2301-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 8MM x 12.5MM Fluted Barrel; REF M-8BA-G1 Cutting shaping bone including spine and cranium.
• Z-2290-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Ball; 9MM REF L-9B-G1 Cutting shaping bone including spine and cranium.
• Z-2296-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 5MM x 11.3MM Fluted Barrel; REF M-5BA-A-G1 Cutting shaping bone including spine and cranium.
• Z-2289-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Extra Coarse Diamond Ball; 8MM REF L-8DX-G1 Cutting shaping bone including spine and cranium.
• Z-2300-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 7MM Extra Coarse Diamond Ball; REF M-7DX-G1 Cutting shaping bone including spine and cranium.
• Z-2288-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 8MM x 14MM Fluted Drum, Side Cut Only; REF L-8DRC-G1. Cutting shaping bone including spine and cranium.
• Z-2307-2015 · Apr 13, 2015 · Terminated
  ANSPACH -4MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-4DC-22-G1 Cutting shaping bone including spine and cranium.
• Z-2292-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 3MM Course Diamond Ball, 2 MM Shaft Exposure; REF M-3DC-2-G1 Cutting shaping bone including spine and cranium.
• Z-2291-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Drum, Side Cut Only; 9MM x 14 MM REF L-9DRC-G1 Cutting shaping bone including spine and cranium.
• Z-2310-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 5MM Diamond Ball, 2MM Shaft Exposure; REF S-5D-2-G1 Cutting shaping bone including spine and cranium.

…and 24 more.