NA CSR60-G1Recalls & reported problems

Summary

The FDA's MAUDE database contains 112 adverse event reports that list this exact device (DI 00845384016434), received between Dec 26, 2017 and Aug 13, 2025 — classified as 112 malfunctions.

The most frequently reported specific device problem is “Vibration” (64 reports).

11 other recalls cover devices cleared under the same FDA submission (K133604); 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 112 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2025Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THE PERFORATOR DRIVER DEVICE WAS OVERHEATING. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22795630 ↗
• MalfunctionJun 26, 2025Break; Fail-Safe Problem; Appropriate Device Problem Term/Code Not Available; Complete Loss of Power; Break; Fail-Safe Problem; Appropriate Device Problem Term/Code Not Available; Complete Loss of Power

  IT WAS REPORTED THAT THE PERFORATOR DEVICE WAS BROKEN AND WOULD NOT ENGAGE. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE RAN IN THE LOCKED POSITION AND HAD COMPONENT DAMAGE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR SPEED ASSESSMENT. 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 22335180 ↗
• MalfunctionNov 8, 2024Vibration; Noise, Audible; Excessive Heating; Difficult or Delayed Separation; Vibration; Noise, Audible; Excessive Heating; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE PERFORATOR DRIVER DEVICE GENERATED HEAT, WAS DIFFICULT TO CONNECT AND REMOVE MOTOR, AND HAD ABNORMAL NOISE AND VIBRATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EVENT DATE WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN (B)(6) 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20640695 ↗
• MalfunctionJul 2, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THE PERFORATOR DEVICE WAS UNUSALLY 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 EXACT DATE OF THE 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 19659321 ↗
• MalfunctionJan 5, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM FRANCE THAT THE PERFORATOR DRIVER 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 18455156 ↗
• MalfunctionDec 15, 2023Excessive Heating; Excessive Heating

  REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED FROM CANADA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE PERFORATOR DRIVE DEVICE AND HANDPIECE DEVICE BECAME VERY HOT DURING THE PROCEDURE OF DRILLING HOLES IN THE CRANIUM FOR A CRANIOTOMY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. 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 18333607 ↗
• MalfunctionNov 14, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE ATTACHMENT DEVICE HAD ABNORMALLY HIGH TEMPERATURE. 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 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 18131772 ↗
• MalfunctionNov 8, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING TESTING, IT WAS OBSERVED THAT THE ATTACHMENT DEVICE WAS OVERHEATING. 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 18093989 ↗
• MalfunctionOct 9, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM TAIWAN THAT THE PERFORATOR 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 17896869 ↗
• MalfunctionAug 29, 2023Environmental Particulates; Complete Loss of Power; Excessive Heating; Environmental Particulates; Complete Loss of Power; Excessive Heating

  THIS IS EVENT 2 OF 2 OF THE SAME EVENT. IT WAS REPORTED THAT THE MOTOR DEVICE AND THE PERFORATE DRIVER HEATED UP, HAD A BURNING SMELL AND HAD LOW POWER. 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. 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 17644373 ↗
• MalfunctionJul 28, 2023Complete Loss of Power; Fail-Safe Did Not Operate; Complete Loss of Power; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE PERFORATOR DRIVER DEVICE DID NOT WORK AS EXPECTED. THE REPORTER STATED THAT THEY OBSERVED THE DEVICE BEING UTILIZED AND ATTEMPTED TO CREATE FOUR BURR HOLES. HOWEVER, NONE OF THEM PENETRATED THE BONE, AS THE CLUTCH BEGAN TO SPIN FREELY. IT WAS REPORTED THAT THERE WERE NO DELAYS IN 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. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17414032 ↗
• MalfunctionJul 25, 2023Complete Loss of Power; Excessive Heating; Complete Loss of Power; Excessive Heating

  THIS IS REPORT 2 OF 2 OF THE SAME EVENT: IT WAS REPORTED FROM JAPAN THAT THE MOTOR DEVICE AND PERFORATOR DRIVER DEVICE WERE HAVING DIFFICULTY CUTTING AND GENERATING HEAT WHILE BEING USED TOGETHER. 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 17388273 ↗
• MalfunctionJul 11, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED BY NETHERLANDS THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE PERFORATOR DRIVER DEVICE GENERATED HEAT. IT WAS FURTHER OBSERVED THAT THE DEVICE HAD VIBRATION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VIBRATION ASSESSMENT AND TEMPERATURE 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 BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17297682 ↗
• MalfunctionJun 26, 2023Device Slipped; Detachment of Device or Device Component; Device Slipped; Detachment of Device or Device Component

  IT WAS REPORTED FROM CANADA THAT PRIOR TO A CRANIOTOMY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SPRING OF THE PERFORATED DRIVER DEVICE WAS COMING OUT ALONG WITH ANOTHER PIECE. DURING FURTHER FOLLOW UP IT WAS REPORTED THAT THE SPRING WAS COMPLETELY OUT OF THE DEVICE AND WAS LOOSE. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO 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 17201090 ↗
• MalfunctionMay 10, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING PRE-SURGERY, IT WAS DISCOVERED THAT THE ATTACHMENT DEVICE WAS OVERHEATING WHEN IN USE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. 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 16903307 ↗
• MalfunctionApr 25, 2023Device Slipped; Detachment of Device or Device Component; Device Slipped; Detachment of Device or Device Component

  IT WAS REPORTED FROM THE NETHERLANDS THAT THE RING ON THE COMPACT SPEED REDUCER DEVICE WAS LOOSE, AND A SMALL PIN CAME OUT OF THE ATTACHMENT. 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 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 16808831 ↗
• MalfunctionApr 25, 2023Device-Device Incompatibility; Environmental Particulates; Noise, Audible; Excessive Heating; Device-Device Incompatibility; Environmental Particulates; Noise, Audible; Excessive Heating

  IT WAS REPORTED FROM THE NETHERLANDS THAT DURING A CRANIOTOMY PROCEDURE, IT WAS DISCOVERED THAT THE PERFORATOR DRIVER DEVICE PRODUCED A LOT OF NOISE, STARTED TO PRODUCE SMOKE AND THE SPEED REDUCER STARTED TO GET UNUSUALLY WARM. IT WAS REPORTED THAT WHEN THE DEVICE WAS INSPECTED THE GEARS APPEARED NOT TO WORK ANYMORE AND THE DRIVE SHAFT DID NOT ENGAGE WITH THE OUTPUT SHAFT. THERE WAS A FIFTEEN-MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS 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 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 16805570 ↗
• MalfunctionApr 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED FROM JAPAN THAT THE INNER RING OF THE COMPACT SPEED REDUCER DEVICE CAME 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, 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 16777397 ↗
• MalfunctionFeb 22, 2023Appropriate Device Problem Term/Code Not Available; Excessive Heating; Appropriate Device Problem Term/Code Not Available; Excessive Heating

  IT WAS REPORTED THAT DURING PRE-SURGERY, IT WAS DISCOVERED THAT THE ATTACHMENT DEVICE WAS OVERHEATING. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16416839 ↗
• MalfunctionFeb 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED FROM JAPAN THAT PARTS FROM THE PERFORATOR DRIVER DEVICE CAME OFF. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN (B)(6) 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 16378289 ↗
• MalfunctionJan 10, 2023Environmental Particulates; Excessive Heating; Environmental Particulates; Excessive Heating

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE PERFORATOR DRIVER DEVICE AND MOTOR DEVICE WERE OVERHEATING, AND SMOKING WHILE BEING USED TOGETHER. IT WAS REPORTED THAT THERE WAS A DELAY IN THE SURGICAL PROCEDURE; HOWEVER, THE DURATION OF THE DELAY WAS NOT SPECIFIED. IT WAS NOT REPORTED WHETHER SPARE DEVICES WERE 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 16131089 ↗
• MalfunctionDec 9, 2022Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING STERILE PROCESSING IT WAS OBSERVED THAT THE COMPACT SPEED REDUCER DEVICE WAS HEATING UP. 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 15952186 ↗
• MalfunctionOct 3, 2022Environmental Particulates; Excessive Heating; Environmental Particulates; Excessive Heating

  THIS IS REPORT 2 OF 2 OF THE SAME EVENT: IT WAS REPORTED FROM PORTUGAL THAT THE MOTOR DEVICE AND PERFORATOR DRIVER DEVICE HEATED UP AND SOME SMOKE CAME OUT OF THEM WHILE BEING USED TOGETHER. 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) 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 15529203 ↗
• MalfunctionSep 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE NETHERLANDS THAT PRIOR TO THE START OF A CRANIAL SURGICAL PROCEDURE, UPON OPENING OF THE SURGICAL SET, IT WAS DISCOVERED THAT THE CONNECTOR ON THE COMPACT SPEED REDUCER DEVICE WAS FOUND DISCONNECTED FROM THE DEVICE RENDERING IT USELESS FOR THE SURGERY. ACCORDING TO THE REPORTER, THE DEVICE WAS DELIVERED TO THE HOSPITAL THREE MONTHS AGO AND HAD BEEN USED IN TWO PREVIOUS SURGERIES. IT WAS REPORTED THAT IT WAS PROBABLE THAT THE DEVICE FELL APART DURING THE CLEANING PROCEDURE ALTHOUGH THE CAUSE AND THE MOMENT OF THE DEFECT WAS UNKNOWN. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS 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. 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 15500412 ↗
• MalfunctionAug 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED FROM NETHERLANDS THAT DURING A CRANIAL PRE-SURGERY, IT WAS DISCOVERED THAT THE CONNECTOR PART OF THE PERFORATOR DRIVER DEVICE DISCONNECTED FROM THE DEVICE. IT WAS FURTHER REPORTED THAT THE DEVICE PROBABLY FELL APART DURING THE CLEANING PROCEDURE, ALTHOUGH THE CAUSE AND MOMENT OF DEFECT COULD NOT BE RECOVERED. IT WAS REPORTED THAT THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE AS THE SURGERY HAD NOT YET BEGUN WHEN THE ISSUE OCCURRED. IT WAS REPORTED THAT 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. 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 15198311 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133604. 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-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-0924-2023 · Dec 7, 2022 · Open, Classified
  Pediatric Craniotome Ref:CRANI-P-G1
• 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-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-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-2253-2016 · Jun 15, 2016 · Terminated
  Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting and shaping bone including bones of the cranium and spine.
• Z-1037-2015 · Dec 10, 2014 · Terminated
  16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cranium. Model MIA16-G1