NA QD14Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 00845384006398), received between Aug 24, 2018 and Apr 30, 2024 — classified as 78 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (38 reports).

70 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. 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 25 most recent of 78 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2024Vibration; Complete Loss of Power; Excessive Heating; Vibration; Complete Loss of Power; Excessive Heating

  IT WAS REPORTED FROM INDIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CUTTER DEVICE COULD NOT BE INSERTED INTO THE ATTACHMENT DEVICE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CUTTER INSERTION, VIBRATION ASSESSMENT, AND TEMPERATURE ASSESSMENT. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. 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 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 19215880 ↗
• MalfunctionApr 18, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM TAIWAN THAT THE ATTACHMENT DEVICE BECAME UNUSUALLY WARM. 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 19135986 ↗
• MalfunctionFeb 22, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED, FROM TAIWAN. THAT THE ATTACHMENT DEVICE HAD BECOME UNUSUALLY WARM. 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. 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 18763194 ↗
• MalfunctionSep 15, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM TAIWAN THAT THE ATTACHMENT DEVICE WAS HEATING UP. 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 17759557 ↗
• MalfunctionJul 27, 2023Appropriate Device Problem Term/Code Not Available; Excessive Heating; Difficult or Delayed Separation; Appropriate Device Problem Term/Code Not Available; Excessive Heating; Difficult or Delayed Separation

  IT WAS REPORTED BY NETHERLANDS THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE GENERATED HEAT. IT WAS FURTHER OBSERVED THAT THE DEVICE HAD A WORN GEAR, AND THE CUTTER DEVICE COULD NOT BE INSERTED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CUTTER INSERTION AND TEMPERATURE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT FUNCTIONING PROPERLY. IT WAS FURTHER REPORTED THAT THE DRILL DEVICE HAD DIFFICULTY SLIDING THOUGH 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. 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17405477 ↗
• MalfunctionJul 13, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM TAIWAN THAT THE ATTACHMENT DEVICE BECAME UNUSUALLY WARM. 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 17315154 ↗
• MalfunctionJul 5, 2023Vibration; Excessive Heating; Vibration; Excessive Heating

  IT WAS REPORTED FROM JAPAN THAT THE MOTOR DEVICE WAS GENERATING HEAT. 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 17262575 ↗
• MalfunctionJun 22, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE ATTACHMENT DEVICE WAS HEATING UP. IT WAS REPORTED THAT THERE WAS A SLIGHT DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS NOT REPORTED IF THERE WAS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17186804 ↗
• MalfunctionMar 24, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THE ATTACHMENT DEVICE HAD AN UNDETERMINED ALLEGATION. DURING SERVICE AND EVALUATION, IT WAS OBSERVED THAT THE DEVICE PRODUCED HEAT, EXHIBITED VIBRATION AND HAD COSMETIC DAMAGE. IT WAS FURTHER REPORTED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT, VIBRATION AND TEMPERATURE. 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 16609652 ↗
• MalfunctionFeb 15, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM TAIWAN THAT THE ATTACHMENT DEVICE BECAME UNUSUALLY WARM. 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 16380012 ↗
• MalfunctionJan 20, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM TAIWAN THAT THE ATTACHMENT DEVICE BECAME UNUSUALLY WARM. 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 16215185 ↗
• MalfunctionDec 13, 2022Break; Excessive Heating; Break; Excessive Heating

  IT WAS REPORTED THAT THE ATTACHMENT DEVICE WAS DAMAGED AND OVERHEATING DURING USE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS HAVING HEATING ISSUES DUE TO MISALIGNMENT OF THE BEARINGS. 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 15972134 ↗
• MalfunctionDec 13, 2022Break; Excessive Heating; Break; Excessive Heating

  IT WAS REPORTED THAT THE ATTACHMENT DEVICE WAS OVERHEATING DURING USE. IT WAS NOTED THAT THE DEVICE WAS HAVING HEATING ISSUES DUE TO MISALIGNED BEARINGS. 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 15971959 ↗
• MalfunctionDec 12, 2022Appropriate Device Problem Term/Code Not Available; Excessive Heating; Appropriate Device Problem Term/Code Not Available; Excessive Heating

  IT WAS REPORTED BY GERMANY THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT ATTACHMENT DEVICE WAS GENERATING HEAT. IT WAS FURTHER OBSERVED THAT THE DEVICE HAD VIBRATION AND COULD NOT REMOVE CUTTER. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CUTTER INSERTION, 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 2022. 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 15963756 ↗
• MalfunctionSep 2, 2022Vibration; Complete Loss of Power; Excessive Heating; Vibration; Complete Loss of Power; Excessive Heating

  IT WAS REPORTED FROM INDIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE HAD A WORN BEARING, A CUTTER COULD NOT BE INSERTED, VIBRATION, AND HEAT. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR NOSE TUBE ASSEMBLY, CUTTER INSERTION, VIBRATION, AND HEAT. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. 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 2022. 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 15350376 ↗
• MalfunctionAug 25, 2022Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM TAIWAN THAT THE ATTACHMENT DEVICE BECAME UNUSUALLY WARM. 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 2022. 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 15295040 ↗
• MalfunctionAug 22, 2022Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM TAIWAN THAT THE ATTACHMENT DEVICE BECAME UNUSUALLY WARM. 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 2022. 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 15264527 ↗
• MalfunctionAug 16, 2022Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THE ATTACHMENT DEVICE HEATED UP. 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 15236603 ↗
• MalfunctionJun 17, 2022Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ATTACHMENT DEVICE HAD HEATING ISSUES AND WOULD NOT HOLD THE CRANIOTOME DEVICE. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2022. 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 14734197 ↗
• MalfunctionMar 23, 2022Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM (B)(6) THAT DURING PRE-SURGERY, IT WAS DISCOVERED THAT THE MOTOR DEVICE HAD A HEATING ISSUE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS 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 UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13869512 ↗
• MalfunctionJan 5, 2022Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM (B)(6) THAT THE ATTACHMENT DEVICE WAS BECOMING UNUSUALLY WARM. 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 (B)(6) 2021. 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 13170756 ↗
• MalfunctionSep 22, 2021Device Slipped; Excessive Heating; Device Slipped; Excessive Heating

  IT WAS REPORTED THAT THE ATTACHMENT DEVICE WAS HEATING UP AND BURR FELT LOOSE. 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12512348 ↗
• MalfunctionAug 20, 2021Break; Excessive Heating; Break; Excessive Heating

  IT WAS REPORTED BY(B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BEARING OF THE ATTACHMENT DEVICE WAS WORN AND THE DEVICE EXPERIENCED VIBRATION, HEAT AND COMPONENT DAMAGE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR THIMBLE SET SCREW, VIBRATION AND TEMPERATURE. IT WAS NOTED IN THE SERVICE ORDER THAT THE BEARING WAS DAMAGED. 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 12349499 ↗
• MalfunctionAug 10, 2021Complete Loss of Power; Excessive Heating; Complete Loss of Power; Excessive Heating

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE HAD BEARING DAMAGE, HEAT AND FAILED PRE-TEST FOR TEMPERATURE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. 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 2021. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, AN ADDITIONAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12302932 ↗
• MalfunctionJul 16, 2021Vibration; Vibration

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ANGLE ATTACHMENT DEVICE WAS DAMAGED, HAD VIBRATION, AND THE ETCHING WAS ILLEGIBLE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VIBRATION, AND LABELING 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 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 12180760 ↗

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-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-0924-2023 · Dec 7, 2022 · Open, Classified
  Pediatric Craniotome Ref:CRANI-P-G1
• 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-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-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-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-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-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-1951-2017 · Oct 6, 2016 · Terminated
  eMax2 Hybrid Hand Control Product Usage: Electric system
• Z-2029-2017 · Oct 6, 2016 · Terminated
  5.0cm Short Attachment
• Z-1933-2017 · Oct 6, 2016 · Terminated
  Foot control irrigation system Product Usage: Pneumatic system
• Z-1931-2017 · Oct 6, 2016 · Terminated
  AL-III W/ male disconnect and 20ft hose Product Usage: Pneumatic system
• Z-2024-2017 · Oct 6, 2016 · Terminated
  8cm QD Angle Attachment
• Z-2027-2017 · Oct 6, 2016 · Terminated
  SMALL ATTACHMENT, JACOBS CHUCK

…and 55 more.