NA LONGRecalls & reported problems

Summary

The FDA's MAUDE database contains 130 adverse event reports that list this exact device (DI 00845384003571), received between Nov 29, 2017 and May 5, 2025 — classified as 1 injury, 129 malfunctions.

The most frequently reported specific device problem is “Vibration” (49 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 130 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2025Device-Device Incompatibility; Excessive Heating; Device-Device Incompatibility; Excessive Heating

  IT WAS REPORTED THAT DURING DEVICE INSPECTION IT WAS OBSERVED THAT THE ATTACHMENT DEVICE HAD DIFFICULTY LOCKING ONTO THE DRILL DEVICE AND WAS RUNNING HOT. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21964478 ↗
• MalfunctionMay 5, 2025Device-Device Incompatibility; Excessive Heating; Device-Device Incompatibility; Excessive Heating

  IT WAS REPORTED THAT DURING DEVICE INSPECTION IT WAS OBSERVED THAT THE 1.0 CM LONG ATTACHMENT DEVICE HAD DIFFICULTY LOCKING ONTO THE DRILL AND WAS RUNNING HOT. 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 21964243 ↗
• MalfunctionMar 7, 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 18856523 ↗
• MalfunctionFeb 20, 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 18737409 ↗
• MalfunctionJan 29, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED BY SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE COULD NOT INSERT CUTTER, HAD ILLEGIBLE LABELING ETCH, FELL APART-UNATTACHED, COULD NOT INSERT CUTTER, HAD MISSING COMPONENTS, NOSE TUBE WAS BENT/DAMAGED AND HAD BEARING DAMAGE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VERIFICATION: VISUAL ASSESSMENT, LOCK OPERATION AND CUTTER INSERTION. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD BEARING DAMAGE. IT WAS NOTED THAT THE BALL BEARINGS WERE FALLEN APART, INTERNAL PARTS OF THE BALL BEARING WERE MISSING, THE EXTENSION SLEEVE HAD BEEN DAMAGED AS A RESULT AND THE LABELING WAS SCRATCHED AND ALMOST ILLEGIBLE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18597075 ↗
• MalfunctionJan 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TESTING, IT WAS OBSERVED THAT THE BEARINGS OF THE ATTACHMENT DEVICE WERE OUT. THE EVENT WAS NOT RELATED TO SURGERY. 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18517275 ↗
• MalfunctionSep 18, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED FROM SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE WAS MISSING COMPONENTS, THE NOSE TUBE WAS BENT, THE ETCHING WAS ILLEGIBLE, THE BEARING WAS DAMAGED, THE COLOR BAND WAS CHIPPING/FADING, COULD NOT SECURE/LOCK THE CUTTER DEVICE AND COULD NOT INSERT THE CUTTER DEVICE AND FELL APART - UNATTACHED. IT AS ALSO FURTHER NOTED THAT THE BALL BEARINGS HAD FALLEN APART AND THE INTERNAL PARTS OF THE BALL BEARINGS WERE MISSING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETESTS FOR LABELING ASSESSMENT, VISUAL ASSESSMENT, COLOR BAND VISUAL ASSESSMENT, LOCK OPERATION AND CUTTER INSERTION. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE 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 17765020 ↗
• MalfunctionSep 1, 2023Break; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Break; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE BEARING OF THE ATTACHMENT DEVICE WERE GOING OUT. 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. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17670844 ↗
• MalfunctionApr 19, 2023Break; Excessive Heating; Break; Excessive Heating

  IT WAS REPORTED FROM SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE LONG ATTACHMENT DEVICE WAS UNABLE TO BE ASSEMBLED/DISASSEMBLED, HAD HEAT AND VIBRATION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VIBRATION, TEMPERATURE ASSESSMENT. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD BEARING DAMAGE. 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 16770990 ↗
• MalfunctionApr 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE PRONGS FROM THE ATTACHMENT DEVICE WERE PULLING OUT AND COMING APART. IT WAS REPORTED THAT THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE AS 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. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16665936 ↗
• MalfunctionMar 30, 2023Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ATTACHMENT DEVICE BEARINGS WERE OUT AND THE CUTTER DEVICE COULD NOT GO THROUGH. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. A 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. 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 16643184 ↗
• MalfunctionJan 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE LONG ATTACHMENT CAME DISLODGED FROM BASE. THE ISSUE WAS OBSERVED DURING PRE-OP INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. AN EXCHANGE DEVICE(S) WILL BE SENT TO THE ACCOUNT AND THEY HAVE BEEN REQUESTED TO RETURN THE CORRESPONDING COMPLAINT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16082281 ↗
• MalfunctionDec 23, 2022Complete Loss of Power; Excessive Heating; Complete Loss of Power; Excessive Heating

  IT WAS REPORTED FROM INDIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE WAS HEATING UP. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST 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 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 16042717 ↗
• MalfunctionDec 23, 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 16042605 ↗
• MalfunctionOct 28, 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 15691246 ↗
• MalfunctionSep 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED FROM SOUTH KOREA THAT A COMPONENT OF THE ATTACHMENT BECAME SEPARATED. 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. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432740 ↗
• MalfunctionSep 1, 2022Excessive 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 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 15336759 ↗
• MalfunctionAug 26, 2022Excessive Heating; Excessive Heating

  IT WAS REPORTED BY SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE WAS GENERATING HEAT. IT WAS FURTHER OBSERVED THAT THE DEVICE HAD COLOR BAND CHIPPING/FADING, ILLEGIBLE ETCH (TRIANGLE SYMBOL WAS MISSING AND LETTERING WAS ILLEGIBLE), STIFF/STUCK LOCKING MECHANISM AND VIBRATION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR LABELING ASSESSMENT, VERIFICATION FOR COLOR BAND VISUAL ASSESSMENT, VERIFICATION FOR LOCK OPERATION, VERIFICATION FOR VIBRATION, AND VERIFICATION FOR 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 15304558 ↗
• MalfunctionJul 21, 2022Device-Device Incompatibility; Excessive Heating; Device-Device Incompatibility; Excessive Heating

  IT WAS REPORTED BY SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT ATTACHMENT DEVICE WAS GENERATING HEAT. IT WAS FURTHER OBSERVED THAT THE DEVICE HAD VIBRATION, DAMAGED BEARING, ILLEGIBLE ETCH AND DAMAGED/BENT NOSE TUBE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR LABELING ASSESSMENT, VISUAL ASSESSMENT VERIFICATION, VIBRATION VERIFICATION, AND TEMPERATURE VERIFICATION. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT HOLDING CUTTERS. 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 15076594 ↗
• MalfunctionApr 27, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED BY (B)(4) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BALL BEARING OF THE ATTACHMENT DEVICE HAD FALLEN APART AND THE INTERNAL PARTS WERE MISSING (FELL APART ¿ UNATTACHED). IT WAS FURTHER OBSERVED THAT THE CUTTER DEVICE COULD NOT BE INSERTED, THE MOTOR WAS WORN, AND THE DEVICE WAS MISSING COMPONENTS. IT WAS DETERMINED THAT THE NOSE TUBE WAS BENT/DAMAGED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR LOCK OPERATION AND CUTTER INSERTION. 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 14224570 ↗
• MalfunctionDec 15, 2021Break; Excessive Heating; Break; Excessive Heating

  IT WAS REPORTED FROM SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE HAD BEARING DAMAGE, THE LABELING WAS DAMAGED, A CUTTER COULD NOT BE INSERTED, HEAT, AND VIBRATION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR LABELING ASSESSMENT, VISUAL ASSESSMENT, CUTTER INSERTION, VIBRATION ASSESSMENT, AND TEMPERATURE ASSESSMENT. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD BEARING DAMAGE. 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 13012648 ↗
• MalfunctionNov 22, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT ATTACHMENT DEVICE HAD BEARING DAMAGE, DAMAGED/BENT NOSE TUBE, MISSING COMPONENTS, AND ILLEGIBLE ETCH. IT WAS DETERMINED THAT THE DEVICE COULD NOT INSERT CUTTER AND FELL APART (UNATTACHED). IT WAS OBSERVED THAT DUE TO DISPROPORTIONATE FORCE, THE BALL BEARINGS WERE DESTROYED. THE BALL BEARINGS HAD FALLEN APART AND INTERNAL PARTS OF THE BALL BEARING WERE MISSING. IT WAS FURTHER OBSERVED THAT THE EXTENSION SLEEVE WAS MASSIVELY DAMAGED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR LABELING ASSESSMENT AND CUTTER INSERTION. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD TUBE AND BEARING DAMAGE. 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 12852366 ↗
• MalfunctionSep 1, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BALL BEARINGS OF THE ATTACHMENT DEVICE HAD FALLEN APART, AND THE INTERNAL PARTS WERE MISSING. IT WAS FURTHER OBSERVED THAT THE DEVICE HAD DAMAGED BEARING, MISSING COMPONENTS, COSMETIC DAMAGE ¿ WORN, AND THE CUTTER DEVICE COULD NOT BE INSERTED NOR SECURED/LOCKED. IT WAS DETERMINED THAT THE DEVICE FELL APART ¿ UNATTACHED AND THE LABELING WAS ILLEGIBLE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR LABELING ASSESSMENT, LOCK OPERATION, AND CUTTER INSERTION. 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 12409312 ↗
• MalfunctionJul 29, 2021Break; Vibration; Break; Vibration

  IT WAS REPORTED THAT PRIOR TO SURGERY, IT WAS OBSERVED THAT THE ATTACHMENT DEVICE BEARING WAS BAD. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE BEARING WAS DAMAGED AND WAS VIBRATING. THE DEVICE ALSO FAILED PRETEST FOR 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 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 12245635 ↗
• MalfunctionJul 23, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BALL BEARING OF THE ATTACHMENT DEVICE FELL APART AND THE INTERNAL PARTS WERE MISSING. IT WAS FURTHER OBSERVED THAT THE BEARINGS WERE DAMAGED, THE CUTTER COULD NOT BE INSERTED OR SECURED/LOCKED, AND THE NOSE TUBE WAS BENT/DAMAGED. IT WAS DETERMINED THAT THE DEVICE HAD MISSING COMPONENTS, COSMETIC DAMAGE ¿ WORN, AND IT FELL APART ¿ UNATTACHED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR LABELING ASSESSMENT, VERIFICATION: LOCK OPERATION AND VERIFICATION: CUTTER INSERTION. 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 12217655 ↗

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-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-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-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-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-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-2022-2017 · Oct 6, 2016 · Terminated
  14cm 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-1988-2017 · Oct 6, 2016 · Terminated
  Rotating Adult Craniotome Product Usage: Pneumatic system
• Z-2025-2017 · Oct 6, 2016 · Terminated
  7.5cm QD Angle Attachment
• Z-2029-2017 · Oct 6, 2016 · Terminated
  5.0cm Short Attachment
• Z-2023-2017 · Oct 6, 2016 · Terminated
  14cm QD Angle Attachment

…and 55 more.