NA CRANI-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 772 adverse event reports that list this exact device (DI 00845384001720), received between Nov 29, 2017 and Sep 9, 2026 — classified as 3 injuries, 769 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (381 reports).

1 FDA recall record name this device's identifier, 1 still open.

69 other recalls cover devices cleared under the same FDA submission (K011444); 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.

Recalls naming this device

1. Dec 7, 2022Open, Classified

   Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury

   Z-0916-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 772 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50698415 ↗
• MalfunctionSep 9, 2026Break; Device Damaged by Another Device

  It was reported that during service and evaluation, it was determined that the 6.5CM ADULT CRANI ATTACHMT device Neuro-Tip Bent/Damaged. It was noted in the service order that the device had bearing failure. 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 50695985 ↗
• MalfunctionSep 2, 2026Device Damaged by Another Device; Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50567578 ↗
• MalfunctionAug 26, 2026Break; Device Reprocessing Problem; Device Damaged by Another Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50461124 ↗
• MalfunctionFeb 25, 2026Break; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE NEURO-TIP OF THE CRANIOTOME DEVICE WAS BENT/DAMAGED, HAD COSMETIC DAMAGE, THE CUTTER COULD NOT BE INSERTED, AND THERE WAS BEARING DAMAGE. IT WAS NOTED THAT THE RIGID GUARD WAS SCRATCHED, THE BAR COULD NOT BE INSERTED (BEARING DETACHED), AND THE COLOR LABEL WAS DETERIORATED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT, COLOR BAND ASSESSMENT, AND CUTTER INSERTION. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD BEARING DAMAGE. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 2026. 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 24443742 ↗
• MalfunctionFeb 5, 2026Device Damaged by Another Device

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE NEURO-TIP ON THE CRANIOTOME ATTACHMENT DEVICE WAS BENT/DAMAGED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24271870 ↗
• MalfunctionJan 23, 2026Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT WHILE USING THE 6.5CM ADULT CRANI ATTACHMT DEVICE IT WAS DIFFICULT TO REMOVE THE CUTTER. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. 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 24168343 ↗
• MalfunctionJan 7, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CRANIOTOME DEVICE PARTS CAME OFF DURING ATTACHMENT CLEANING. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. 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 23988793 ↗
• MalfunctionJan 7, 2026Material Fragmentation

  IT WAS REPORTED THAT THE CRANIOTOME DEVICE GUARD HAS BEEN BROKEN. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. 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." ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23988771 ↗
• MalfunctionJan 6, 2026Device Damaged by Another Device; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE NEURO TIP OF THE CRANIOTOME DEVICE WAS BENT/DAMAGED, THE DEVICE HAD A WORN BEARING, AND WAS DIFFICULT TO ASSEMBLE/DISASSEMBLE. IT WAS NOTED THAT THERE WAS A DURA GUARD WOUND, THE MOTOR CONNECTION WAS SNAGGED, AND THE BAR WAS SNAGGED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT, LOCK OPERATION ASSESSMENT, AND CUTTER INSERTION ASSESSMENT. IT WAS NOTED IN THE SERVICE ORDER THAT IT WAS DIFFICULT TO REMOVE THE CUTTER FROM THE DEVICE. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 2025. 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 23974814 ↗
• MalfunctionJan 6, 2026Vibration; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CRANIOTOME DEVICE NEURO TIP WAS BENT/DAMAGED. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD VIBRATION. 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 THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973537 ↗
• MalfunctionDec 23, 2025Break; Device Damaged by Another Device; Break; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SMALL BATTERY DRIVE DEVICE HAD THE FOLLOWING ERROR: VISUAL: CRANIOTOME NEURO-TIP BENT/DAMAGED. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE HAD COMPONENT DAMAGE. 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 23878844 ↗
• MalfunctionDec 12, 2025Break; Device Damaged by Another Device; Break; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE NEURO TIP OF THE CRANIOTOME DEVICE WAS BENT/DAMAGED. IT WAS NOTED IN THE SERVICE ORDER THAT THE BEARINGS WERE DAMAGED. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 2025. 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 23791471 ↗
• MalfunctionDec 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BEARING ON THE CRANIOTOME DEVICE CAME OFF. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23714317 ↗
• MalfunctionNov 24, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CRANIOTOME ATTACHMENT DEVICE BEARING WAS HAD FALLEN OFF. 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. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630397 ↗
• MalfunctionNov 20, 2025Break; Device Damaged by Another Device; Break; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CRANIOTOME NEURO TIP WAS BENT/DAMAGED AND COLOR BAND WAS CHIPPING/FADING. IT WAS NOTED THAT THE DURA GUARD WAS BROKEN. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT AND VERIFICATION: COLOR BAND VISUAL ASSESSMENT. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD COMPONENT DAMAGE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23603540 ↗
• MalfunctionNov 20, 2025Vibration; Device Damaged by Another Device; Vibration; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CRANIOTOME ATTACHMENT DEVICE PRODUCED UNEXPECTED NOISE, EXHIBITED VIBRATION, WAS DIFFICULT TO ASSEMBLE/DISASSEMBLE AND HAD COSMETIC DAMAGE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT, COLOR BAND VISUAL ASSESSMENT AND VIBRATION. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE EXHIBITED VIBRATION. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23603470 ↗
• MalfunctionNov 14, 2025Device Damaged by Another Device; Difficult or Delayed Separation; Device Damaged by Another Device; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE NEURO-TIP OF THE CRANIOTOME DEVICE WAS BENT/DAMAGED. IT WAS FURTHER DETERMINED THAT THE DEVICE HAD VIBRATION, WAS DIFFICULT TO ASSEMBLE/DISASSEMBLE AND MADE AN UNEXPECTED NOISE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT, LOCK OPERATION AND VIBRATION. IT WAS NOTED IN THE SERVICE ORDER THAT THE CRANIOTOME DEVICE WAS DIFFICULT TO REMOVE FROM THE MOTOR DEVICE. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 23555865 ↗
• MalfunctionNov 14, 2025Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE 6.5CM ADULT CRANI ATTACHMT DEVICE CRANIOTOME NEURO-TIP BENT/DAMAGED. IT WAS NOTED THAT THE CUTTER COULD NOT BE INSERTED AND THERE WAS COMPONENT DAMAGE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555663 ↗
• MalfunctionNov 14, 2025Device Damaged by Another Device; Device-Device Incompatibility; Device Damaged by Another Device; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE NEURO-TIP OF THE CRANIOTOME DEVICE WAS BENT/DAMAGED. IT WAS FURTHER DETERMINED THAT THE DEVICE HAD BEARING DAMAGE, WAS DIFFICULT TO ASSEMBLE/DISASSEMBLE, COULD NOT INSERT THE CUTTER AND THE COLOR BAND WAS CHIPPING/FADING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT, COLOR BAND VISUAL ASSESSMENT, LOCK OPERATION AND CUTTER INSERTION. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD A CONNECTING DEFECT AND COULD NOT BE ASSEMBLED WITH HANDPIECE DEVICE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554306 ↗
• MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CRANIOTOME DEVICE INNER PARTS CAME OFF. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. 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 23486621 ↗
• MalfunctionOct 20, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CRANIOTOME DEVICE COMPONENT DETACHED. IT WAS REPORTED THAT 16 DAYS AGO, DURING THE SURGERY, IT WAS DISCOVERED THAT THE PRESSURE OF THE AIR DRILL WAS INSUFFICIENT, MAKING IT DIFFICULT TO CUT BONES. DURING THE USE, THE BONE WAS UNABLE TO BE SAWED OFF AND THE BEADS WERE FOUND INSIDE THE SLEEVE. THE SURGERY WAS STOPPED AND REPLACED WITH A NEW SLEEVE, AND THE SURGERY PROCEEDED SMOOTHLY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR WHETHER A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23334956 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE 6.5CM ADULT CRANI ATTACHMT DEVICE NEURO-TIP BENT/DAMAGED. IT WAS FURTHER DETERMINED THAT THE DEVICE HAD BEARING DAMAGED, COLOR BAND CHIPPING/FADING, AND CANNOT INSERT CUTTER. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED THE FOLLOWING PRETEST STEPS: VISUAL ASSESSMENT, COLOR BAND VISUAL ASSESSMENT, AND CUTTER INSERTION. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD BEARING DAMAGE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23304364 ↗
• MalfunctionOct 15, 2025Break; Device Damaged by Another Device; Break; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE NEURO-TIP OF THE CRANIOTOME DEVICE WAS BENT/DAMAGED. IT WAS FURTHER DETERMINED THAT THE BEARING WAS DAMAGED, AND THE CUTTER COULD NOT BE INSERTED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT AND CUTTER INSERTION. IT WAS NOTED IN THE SERVICE ORDER THAT THE BEARING WAS DAMAGED. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 23303953 ↗
• MalfunctionOct 15, 2025Break; Device Damaged by Another Device; Break; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE NEURO-TIP OF THE CRANIOTOME DEVICE WAS BENT/DAMAGED. IT WAS FURTHER DETERMINED THAT THE BEARING WAS DAMAGED, THE COLOR BAND WAS CHIPPING/FADING AND THE CUTTER COULD NOT BE INSERTED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT, COLOR BAND VISUAL ASSESSMENT AND CUTTER INSERTION. IT WAS NOTED IN THE SERVICE ORDER THAT THE BEARING WAS DAMAGED. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 23303477 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011444. One submission often covers many models, so check the product and lot details in each record.

• Z-0923-2023 · Dec 7, 2022 · Open, Classified
  6.5 cm Pediatric Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-P Intended for cutting and shaping bone including the spine and cranium
• Z-0920-2023 · Dec 7, 2022 · Open, Classified
  7.5 cm Large Craniotome Attachment Use with XMax, microMax, and eMax Systems. Ref: CRANI-L Intended for cutting and shaping bone including the spine and cranium
• Z-0917-2023 · Dec 7, 2022 · Open, Classified
  6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-A-01 intended for cutting and shaping bone including the spine and crani
• Z-0921-2023 · Dec 7, 2022 · Open, Classified
  Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium
• Z-0924-2023 · Dec 7, 2022 · Open, Classified
  Pediatric Craniotome Ref:CRANI-P-G1
• Z-0919-2023 · Dec 7, 2022 · Open, Classified
  6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-A-R intended for cutting and shaping bone including the spine and cranium
• Z-0918-2023 · Dec 7, 2022 · Open, Classified
  Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and cranium
• Z-0922-2023 · Dec 7, 2022 · Open, Classified
  7.5 cm Large Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-L-R Intended for cutting and shaping bone including the spine and cranium
• Z-1946-2017 · Oct 6, 2016 · Terminated
  Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric system
• Z-1986-2017 · Oct 6, 2016 · Terminated
  Adult Craniotome Product Usage: Pneumatic system
• Z-2022-2017 · Oct 6, 2016 · Terminated
  14cm QD Angle Attachment Product Usage: Pneumatic system
• Z-2029-2017 · Oct 6, 2016 · Terminated
  5.0cm Short Attachment
• Z-2027-2017 · Oct 6, 2016 · Terminated
  SMALL ATTACHMENT, JACOBS CHUCK
• Z-1930-2017 · Oct 6, 2016 · Terminated
  14cm QD Angle Attachment Product Usage: Product attachment
• Z-1951-2017 · Oct 6, 2016 · Terminated
  eMax2 Hybrid Hand Control Product Usage: Electric system

…and 54 more.