NA QD8Recalls & reported problems

Summary

The FDA's MAUDE database contains 386 adverse event reports that list this exact device (DI 00845384006626), received between Nov 21, 2017 and Apr 13, 2026 — classified as 386 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (197 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 386 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SCREW HAD COME OFF THE ATTACHMENT DEVICE. IT WAS NOT REPORTED IF THE DEVICE WAS USED 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 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 24858447 ↗
• MalfunctionFeb 11, 2026Environmental Particulates; Excessive Heating

  IT WAS REPORTED THAT A BURNING SMELL WAS NOTICED AS THE ATTACHMENT DEVICE GENERATED HEAT DURING OPERATION. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN A SURGICAL PROCEDURE, 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 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 24313794 ↗
• MalfunctionNov 26, 2025Leak/Splash; Complete Loss of Power; Leak/Splash; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE MOTOR DEVICE HOSE WAS DAMAGED AND WAS LEAKING A LIQUID. THE DEVICE ALSO FAILED PRETESTS FOR HOSE ASSESSMENT AND OIL LEAK ASSESSMENT. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT FUNCTION. 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23656937 ↗
• MalfunctionNov 5, 2025Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THE 8CM ANGLE ATTACHMENT DEVICE WAS OVERHEATING. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS UNKNOWN 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 23480427 ↗
• MalfunctionOct 23, 2025Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE ATTACHMENT DEVICE HEATED UP A LOT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23365436 ↗
• MalfunctionSep 2, 2025Device-Device Incompatibility; Fail-Safe Did Not Operate; Device-Device Incompatibility; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT THE DRILL BITS DID NOT STAY ATTACHED TO THE XMAX HANDPIECE DEVICE. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS RAN IN THE LOCKED POSITION AND CANNOT SECURE/LOCK CUTTER. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED THE FOLLOWING PRETEST STEPS: CUTTER LOCK ASSESSMENT, MOTOR RUB ASSESSMENT, AND SAFETY ASSESSMENT. 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 22939919 ↗
• MalfunctionAug 19, 2025Device-Device Incompatibility; Excessive Heating; Device-Device Incompatibility; Excessive Heating

  IT WAS REPORTED FROM THAT THE MOTOR DEVICE DRILL BIT DID NOT ATTACH AND THE PERFORATOR WAS OVERHEATING. 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 22837205 ↗
• MalfunctionJul 29, 2025Complete Loss of Power; Excessive Heating; Complete Loss of Power; Excessive Heating

  IT WAS REPORTED THAT THE ATTACHMENT DEVICE DID NOT WORK. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS LOOSE, PRODUCED UNEXPECTED NOISE, EXHIBITED VIBRATION, PRODUCED HEAT AND HAD COSMETIC DAMAGE AND COLOR BAND WAS CHIPPING/FADING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT, THIMBLE SET SCREW, VIBRATION AND TEMPERATURE. 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 22642800 ↗
• MalfunctionJul 15, 2025Mechanical Jam; Excessive Heating; Mechanical Jam; Excessive Heating

  IT WAS REPORTED THAT THE ATTACHMENT DEVICE ROTATION WAS DEFECTIVE. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD COSMETIC DAMAGE, WAS LOOSE, WAS DIFFICULT TO ASSEMBLE/DISASSEMBLE, MADE UNEXPECTED NOISE, WAS VIBRATING AND HEATED UP. THE DEVICE ALSO FAILED PRETESTS FOR VISUAL ASSESSMENT, NOSE TUBE ASSEMBLY, THIMBLE SET SCREW, LOCK OPERATION, VIBRATION AND TEMPERATURE ASSESSMENT. 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 22506209 ↗
• MalfunctionMay 6, 2025Device-Device Incompatibility; Excessive Heating; Device-Device Incompatibility; Excessive Heating

  IT WAS REPORTED THAT THE ATTACHMENT DEVICE HAD A HIGH TEMPERATURE AND MOTOR CONNECTION FAILURE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT MOTOR CONNECTION FAILURE WAS HIGH. 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 21967215 ↗
• MalfunctionApr 30, 2025Appropriate Device Problem Term/Code Not Available; Excessive Heating; Appropriate Device Problem Term/Code Not Available; Excessive Heating

  IT WAS NOTED IN THE SERVICE ORDER THAT THE ATTACHMENT DEVICE HAD AN UNDETERMINED MALFUNCTION. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE GENERATED HEAT. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR TEMPERATURE. 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 21934973 ↗
• MalfunctionMar 26, 2025Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THE ATTACHMENT DEVICE GENERATED HEAT. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS IN THE SURGICAL PROCEDURE. IT WAS UNKNOWN IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS UNKNOWN IF 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21700431 ↗
• MalfunctionMar 19, 2025Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE PRODUCED HEAT. 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21641424 ↗
• MalfunctionMar 5, 2025Excessive Heating; Difficult or Delayed Separation; Excessive Heating; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE ATTACHMENT DEVICE WAS GENERATING HEAT, AND IT WAS DIFFICULT TO INSERT THE BURR DEVICE. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL 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 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 21529318 ↗
• MalfunctionFeb 13, 2025Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE PRODUCED HEAT. IT WAS DETERMINED THAT THE DEVICE HAD VIBRATION, COULD NOT INSERT THE CUTTER AND WAS LOOSE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR THIMBLE SET SCREW, CUTTER INSERTION 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 UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21373733 ↗
• MalfunctionNov 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE INNER PARTS ON THE ATTACHMENT DEVICE FELL OFF. THERE WAS NO PATIENT INVOLVEMENT REPORTED. 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 20797302 ↗
• MalfunctionNov 9, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE BURR CAME OFF THE ATTACHMENT DEVICE. 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20646895 ↗
• MalfunctionNov 5, 2024Break; Leak/Splash; Appropriate Device Problem Term/Code Not Available; Break; Leak/Splash; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE MOTOR DEVICE HAD A HOLE IN THE TUBE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS OBSERVED THAT THE DEVICE HAD LIQUID LEAK AND HOSE DAMAGE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR HOSE ASSESSMENT AND OIL LEAK 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 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 20609499 ↗
• MalfunctionOct 11, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM JAPAN THAT THE ATTACHMENT DEVICE GENERATED 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 FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2024. 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 20427470 ↗
• MalfunctionOct 9, 2024Break; Excessive Heating; Break; Excessive Heating

  IT WAS REPORTED FROM JAPAN THAT THE ATTACHMENT DEVICE WAS GENERATING HEAT AND HAD BEARING DAMAGE. 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) 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 20410531 ↗
• MalfunctionOct 7, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM JAPAN THAT THE ATTACHMENT DEVICE HAD 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 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 20392788 ↗
• MalfunctionOct 4, 2024Leak/Splash; Excessive Heating; Leak/Splash; Excessive Heating

  IT WAS REPORTED FROM JAPAN THAT THE ATTACHMENT DEVICE WAS GENERATING HEAT AND HAD OIL LEAKS. 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) 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 20376606 ↗
• MalfunctionOct 2, 2024Break; Break

  IT WAS REPORTED THAT THE MOTOR DEVICE HAD A HOLE IN THE TUBE PRIOR TO SURGERY. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE TRIGGERS ON THE MOTOR DEVICE HOSE RUPTURED AND HAD COMPONENT DAMAGE. THE DEVICE ALSO FAILED PRETEST FOR VISUAL ASSESSMENT, HOSE ASSESSMENT AND MUFFLER TUBE ASSESSMENT. 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 20351953 ↗
• MalfunctionSep 12, 2024Detachment of Device or Device Component; Excessive Heating; Detachment of Device or Device Component; Excessive Heating

  IT WAS REPORTED FROM JAPAN THAT THE ATTACHMENT DEVICE WAS FALLING 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 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 20202777 ↗
• MalfunctionSep 6, 2024Break; Excessive Heating; Break; Excessive Heating

  IT WAS REPORTED FROM SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE HEATED UP, THE BEARING WAS WORN AND HAD FOREIGN DEBRIS. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR TEMPERATURE ASSESSMENT. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE INNER 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. 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 20157915 ↗

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-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-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-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-0924-2023 · Dec 7, 2022 · Open, Classified
  Pediatric Craniotome Ref:CRANI-P-G1
• 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-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-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-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-1954-2017 · Oct 6, 2016 · Terminated
  Foot Control without Switches, SC2100 Product Usage: Electric system
• Z-1931-2017 · Oct 6, 2016 · Terminated
  AL-III W/ male disconnect and 20ft hose 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-2028-2017 · Oct 6, 2016 · Terminated
  SMALL ATTACHMENT, J-LATCH
• Z-1953-2017 · Oct 6, 2016 · Terminated
  Foot Control, SC2100 Product Usage: Electric system

…and 55 more.