NA CRANI-PRecalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 00845384001775), received between Jan 15, 2018 and Jun 5, 2025 — classified as 74 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (34 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-0923-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 74 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2025Device Markings/Labelling Problem; Device Damaged by Another Device; Device Markings/Labelling Problem; Device Damaged by Another Device

  IT WAS REPORTED THAT THE COLOR LABEL OF THE CRANIOTOME DEVICE WAS DAMAGED. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE NEURO TIP OF THE DEVICE WAS BENT/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 22153155 ↗
• MalfunctionNov 13, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CRANIOTOME DEVICE GENERATED HEAT. IT WAS FURTHER OBSERVED THAT THE EXPERIENCED VIBRATION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VIBRATION AND TEMPERATURE. 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 (B)(6) 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20673728 ↗
• MalfunctionOct 30, 2024Break; Device Damaged by Another Device; Break; Device Damaged by Another Device

  IT WAS REPORTED BY JAPAN THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE NEURO-TIP OF THE CRANIOTOME DEVICE BENT/DAMAGED. IT WAS FURTHER OBSERVED THAT THE DEVICE HAD COSMETIC DAMAGE, WORN BEARING AND VIBRATION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT, COLOR BAND VISUAL ASSESSMENT, CUTTER INSERTION AND VIBRATION. IT WAS NOTED IN THE SERVICE ORDER THAT THE BEARING WAS WORN. 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 (B)(6) 2024. 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 20567286 ↗
• MalfunctionOct 25, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED FROM JAPAN THAT THE GUARD PART OF THE CRANIOTOME DEVICE WAS BROKEN. 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 2024. 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 20532885 ↗
• MalfunctionApr 26, 2024Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED BY JAPAN THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE NEUO-TIP OF THE CRANIOTOME DEVICE WAS BENT/DAMAGED. IT WAS FURTHER OBSERVED THAT THE DEVICE HAD VIBRATION AND WORN BEARING. IT WAS DETERMINED THAT THE DEVICE COULD NOT INSERT CUTTER. 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 2024. 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 19193732 ↗
• MalfunctionApr 19, 2024Vibration; Device Damaged by Another Device; Excessive Heating; Vibration; Device Damaged by Another Device; Excessive Heating

  IT WAS REPORTED FROM JAPAN THAT DURING SERVICE AND REPAIR/PRE-TESTING, IT WAS OBSERVED THAT THE CRANIOTOME DEVICE OVERHEATED, IT WAS DIFFICULT TO ATTACH IT TO THE MOTOR DEVICE, WAS VIBRATING, THE BEARING WAS WORN AND THE DEVICE WAS BENT. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO 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 2024. 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 19143281 ↗
• MalfunctionApr 3, 2024Appropriate Device Problem Term/Code Not Available; Excessive Heating; Appropriate Device Problem Term/Code Not Available; Excessive Heating

  IT WAS REPORTED FROM SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CRANIOTOME DEVICE HEATED UP, THE COLOR BAND WAS CHIPPING, THE ETCHING WAS ILLEGIBLE AND WAS VIBRATING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETESTS FOR LABELING ASSESSMENT, VISUAL ASSESSMENT, COLOR BAND VISUAL ASSESSMENT, VIBRATION AND TEMPERATURE ASSESSMENT. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNDETERMINED MALFUNCTION PRIOR TO SURGERY. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO 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 2024. 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 19037299 ↗
• MalfunctionJan 8, 2024Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE TIP OF THE CRANIOTOME DEVICE WAS BENT. 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. THE EXACT DATE OF THE EVENT IS 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 18464189 ↗
• MalfunctionNov 14, 2023Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED FROM JAPAN THAT THE BURR GUARD ON THE CRANIOTOME DEVICE WAS BENT. 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 2023. 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 18130934 ↗
• MalfunctionOct 24, 2023Break; Device Damaged by Another Device; Break; Device Damaged by Another Device

  IT WAS REPORTED FROM JAPAN THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CRANIOTOME DEVICE NEURO TIP WAS DAMAGED, THE BEARING WAS WORN, WAS VIBRATING, HAD COMPONENT DAMAGE AND THE CUTTER DEVICE COULD NOT BE INSERTED. DURING FURTHER INVESTIGATION IT WAS CLARIFIED THAT THE DURAL GUARD WAS SCRATCHED, THE BAR WAS SNAGGING, MADE EXCESSIVE NOISE AND WAS VIBRATING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETESTS FOR VISUAL ASSESSMENT, CUTTER INSERTION AND VIBRATION. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE BEARING WAS WORN. 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 17996776 ↗
• MalfunctionOct 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED FROM JAPAN THAT THE CRANIOTOME DEVICE FELL APART. 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. 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 17896658 ↗
• MalfunctionAug 18, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE TIP OF THE CRANIOTOME DEVICE WAS BENT OR BROKE. 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. 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 17577844 ↗
• MalfunctionAug 16, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE TIP OF THE CRANIOTOME DEVICE WAS BENT OR BROKEN. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17556579 ↗
• MalfunctionAug 16, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE TIP OF THE CRANIOTOME DEVICE WAS BENT OR BROKE. 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. 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 17556091 ↗
• MalfunctionJun 30, 2023Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED FROM JAPAN THAT DURING SERVICE AND REPAIR/PRE-TESTING, IT WAS OBSERVED THAT THE ATTACHMENT DEVICE OVERHEATED AND IT WAS DIFFICULT TO ATTACH IT TO THE MOTOR 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 DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2023. 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 17239389 ↗
• MalfunctionMay 23, 2023Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED FROM SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE NEURO-TIP OF THE CRANIOTOME DEVICE WAS BENT/DAMAGED, THE BEARING WAS WORN, AND THE ETCHING WAS ILLEGIBLE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR LABELING ASSESSMENT, VISUAL ASSESSMENT, LOCK OPERATION, AND 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 NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2023. 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 16987209 ↗
• MalfunctionMay 12, 2023Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED FROM JAPAN THAT THE CRANIOTOME DEVICE BURR GUARD WAS BENT. 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 BUT WAS KNOWN TO HAVE OCCURRED IN 2023. 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 16924144 ↗
• MalfunctionApr 27, 2023Device Damaged by Another Device; Complete Loss of Power; Device Damaged by Another Device; Complete Loss of Power

  IT WAS REPORTED FROM SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CRANIOTOME DEVICE NEURO-TIP WAS BENT, THE BEARING WAS WORN, COULD NOT INSERT CUTTER AND WAS VIBRATING. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK AT ALL. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF 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 16822740 ↗
• MalfunctionApr 26, 2023Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING SERVICE AND REPAIR/PRE-TESTING, IT WAS OBSERVED THAT THE CRANIOTOME DEVICE BEARING AND NEURO TIP WERE DAMAGED, THE ETCHING WAS ILLEGIBLE AND THE CUTTER COULD NOT BE INSERTED. THE DEVICE ALSO FAILED PRETESTS FOR LABELING ASSESSMENT, VISUAL ASSESSMENT, COLOR BAND VISUAL ASSESSMENT AND CUTTER INSERTION. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO 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 2023. 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 16814564 ↗
• MalfunctionApr 7, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS DISCOVERED THAT THE CRANIOTOME DEVICE WAS GENERATING HEAT. IT WAS FURTHER REPORTED THAT THE DEVICE HAD ILLEGIBLE ETCH AND DAMAGED BEARING. THE EVENT WAS NOT RELATED TO 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 2023. 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 16702233 ↗
• MalfunctionApr 7, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED BY SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CRANIOTOME DEVICE PRODUCED HEAT AND CRANIOTOME NEURO-TIP WAS BENT/DAMAGED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT AND TEMPERATURE. 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 2023. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16699297 ↗
• MalfunctionApr 4, 2023Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED BY SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SMALL BATTERY DRIVE DEVICE HAD MISSING LABELING, ILLEGIBLE LABELING ETCH AND CRANIOTOME NEURO-TIP WAS BENT/DAMAGED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR LABELING ASSESSMENT AND VERIFICATION VISUAL ASSESSMENT. 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 2023. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16673197 ↗
• MalfunctionMar 10, 2023Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED FROM JAPAN THAT THE BURR GUARD OF CRANIOTOME DEVICE WAS BENT. 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 2023. 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 16520330 ↗
• MalfunctionFeb 3, 2023Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED BY SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CRANIOTOME DEVICE NEURO TIP WAS BENT/DAMAGED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT. 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 2022. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16289551 ↗
• MalfunctionJan 26, 2023Material Fragmentation; Device Markings/Labelling Problem; Material Fragmentation; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE L-SHAPED HOOK ON THE CRANIOTOME DEVICE BROKE OFF. 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. THE EXACT DATE OF THE EVENT WAS NOT REPORTED. 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 16248261 ↗

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-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-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-0916-2023 · Dec 7, 2022 · Open, Classified
  6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems. Ref: CRANI-A Intended for cutting and shaping bone including the spine and cranium
• 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-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-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-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-1951-2017 · Oct 6, 2016 · Terminated
  eMax2 Hybrid Hand Control Product Usage: Electric system
• Z-2013-2017 · Oct 6, 2016 · Terminated
  8.0CM Heavy Duty Medium Attachment Product Usage: Pneumatic system
• Z-2020-2017 · Oct 6, 2016 · Terminated
  11cm QD Angle Attachment Product Usage: Pneumatic system
• Z-1932-2017 · Oct 6, 2016 · Terminated
  AL-III W/ male disconnect and 30ft hose Product Usage: Pneumatic system
• Z-1991-2017 · Oct 6, 2016 · Terminated
  Pediatric Craniotome
• Z-2014-2017 · Oct 6, 2016 · Terminated
  16cm Minimally Invasive Attachment Product Usage: Pneumatic system
• Z-1930-2017 · Oct 6, 2016 · Terminated
  14cm QD Angle Attachment Product Usage: Product attachment

…and 54 more.