NA CSR60Recalls & reported problems

Summary

The FDA's MAUDE database contains 221 adverse event reports that list this exact device (DI 00845384001782), received between Nov 29, 2017 and May 28, 2025 — classified as 3 injuries, 218 malfunctions.

The most frequently reported specific device problem is “Vibration” (111 reports).

4 other recalls cover devices cleared under the same FDA submission (K960630); 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 221 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2025Device-Device Incompatibility; Excessive Heating; Device-Device Incompatibility; Excessive Heating

  IT WAS REPORTED THAT THE COMPACT SPEED REDUCER DEVICE WAS OVERHEATING AND THE CUTTER DEVICE WAS NOT STAYING IN. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. 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 22100676 ↗
• MalfunctionMay 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS IS REPORT 1 OF 2 OF THE SAME EVENT: IT WAS REPORTED THAT THE COMPACT SPEED REDUCER DEVICE AND CRANIOTOME DEVICE CAME OFF. 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 21985004 ↗
• MalfunctionApr 23, 2025Noise, Audible; Excessive Heating; Noise, Audible; Excessive Heating

  IT WAS REPORTED THAT THE COMPACT SPEED REDUCER DEVICE GENERATED HEAT AND EMITTED AN ABNORMAL NOISE. 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. 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 21890450 ↗
• MalfunctionMar 26, 2025Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE TIP OF THE COMPACT SPEED REDUCER DEVICE WAS BENT. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE REPORTED. IT WAS UNKNOWN IF A SPARE DEVICE WAS AVAILABLE FOR USE. 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 21701294 ↗
• 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 20646840 ↗
• MalfunctionNov 1, 2024Overheating of Device; Appropriate Device Problem Term/Code Not Available; Noise, Audible; Overheating of Device; Appropriate Device Problem Term/Code Not Available; Noise, Audible

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE COMPACT SPEED REDUCER DEVICE HAD COMPONENT DAMAGE, A WORN BEARING, HEAT, VIBRATION AND UNEXPECTED NOISE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL AND TEMPERATURE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD ABNORMAL NOISE. 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 20585808 ↗
• MalfunctionSep 19, 2024Premature Separation; Premature Separation

  IT WAS REPORTED FROM JAPAN THAT THE COMPACT SPEED REDUCER DEVICE CAME OFF FROM THE MOTOR 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 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 20258207 ↗
• MalfunctionJul 17, 2024Mechanical Jam; Noise, Audible; Excessive Heating; Mechanical Jam; Noise, Audible; Excessive Heating

  IT WAS REPORTED FROM JAPAN THAT THE COMPACT SPEED REDUCER DEVICE GENERATED HEAT, MADE AN ABNORMAL NOISE, AND DID NOT MOVE SMOOTHLY. 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 19760463 ↗
• MalfunctionApr 26, 2024Premature Separation; Premature Separation

  IT WAS REPORTED FROM JAPAN THAT THE COMPACT SPEED REDUCER DEVICE HAD COME OFF THE HANDPIECE DEVICE EASILY. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A DELAY TO A PLANNED PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19197222 ↗
• MalfunctionApr 25, 2024Premature Separation; Premature Separation

  IT WAS REPORTED FROM JAPAN THAT THE COMPACT AIR DRIVE DEVICE CAME OFF EASILY WHILE IN USE WITH THE MOTOR 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 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 19180865 ↗
• MalfunctionApr 19, 2024Premature Separation; Premature Separation

  IT WAS REPORTED FROM JAPAN THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE MOTOR DEVICE WOULD COME OFF/DISENGAGE FROM THE COMPACT SPEED REDUCER DEVICE DURING USE. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE PROCEDURE DUE TO THE EVENT. 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19141427 ↗
• MalfunctionMar 14, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM JAPAN THAT THE ATTACHMENT 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 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 18909276 ↗
• MalfunctionJan 17, 2024Mechanical Problem; Fail-Safe Did Not Operate; Mechanical Problem; Fail-Safe Did Not Operate

  IT WAS REPORTED FROM JAPAN THAT DURING AN CRANIOTOMY SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE COMPACT SPEED REDUCER, WHICH WAS CONNECTED TO ANOTHER PERFORATOR DEVICE, CONTINUED TO ROTATE WHILE THE FOOT PEDAL WAS DEPRESSED. IT WAS FURTHER REPORTED THAT THE RELEASE MECHANISM OF THE DEVICE DID NOT WORK AND THE DURA MATER WAS PERFORATED. THE GEARS OF INNER AND OUTER BLADES WERE RELEASED AND SPINNING IDLE. 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. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18527333 ↗
• MalfunctionDec 15, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING PRE-SURGERY TESTING 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 18335405 ↗
• MalfunctionDec 14, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THE COMPACT SPEED REDUCER DEVICE HEATED UP PRIOR TO SURGERY. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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 18329028 ↗
• MalfunctionNov 30, 2023Excessive Heating; Excessive Heating

  THIS IS REPORT 1 OF 2 OF THE SAME EVENT: IT WAS REPORTED FROM JAPAN THAT THE MOTOR DEVICE AND COMPACT SPEED REDUCER DEVICE WERE 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 18239954 ↗
• MalfunctionAug 30, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM JAPAN THAT THE COMPACT SPEED REDUCER 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. 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 17648887 ↗
• MalfunctionAug 14, 2023Appropriate Device Problem Term/Code Not Available; Noise, Audible; Excessive Heating; Appropriate Device Problem Term/Code Not Available; Noise, Audible; Excessive Heating

  IT WAS REPORTED FROM JAPAN THAT THE COMPACT SPEED REDUCER DEVICE MADE ABNORMAL NOISE AND 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 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 17540708 ↗
• MalfunctionAug 8, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM TAIWAN THAT THE COMPACT SPEED REDUCER 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 17481322 ↗
• MalfunctionAug 3, 2023Noise, Audible; Excessive Heating; Noise, Audible; Excessive Heating

  IT WAS REPORTED FROM JAPAN THAT THE COMPACT SPEED REDUCER GENERATED HEAT AND PRODUCED ABNORMAL NOISE ALONG WITH A MOTOR 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. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17449829 ↗
• MalfunctionJun 30, 2023Complete Loss of Power; Excessive Heating; Complete Loss of Power; Excessive Heating

  IT WAS REPORTED BY SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE COMPACT SPEED REDUCER DEVICE HAD DAMAGED COMPONENTS, DID NOT FUNCTION AND PRODUCED HEAT. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR SPEED AND TEMPERATURE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. 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 17236392 ↗
• MalfunctionJun 16, 2023Mechanical Jam; Premature Separation; Mechanical Jam; Premature Separation

  IT WAS REPORTED FROM CHINA THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT THE COMPACT SPEED REDUCER ADAPTOR DEVICE DETACHED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT AN UNSPECIFIED SPARE DEVICE WAS AVAILABLE FOR USE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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 17144488 ↗
• MalfunctionApr 20, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM TAIWAN THAT THE COMPACT SPEED REDUCER 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 16778930 ↗
• MalfunctionMar 8, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM TAIWAN THAT THE COMPACT AIR DRIVE 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 16502549 ↗
• MalfunctionFeb 3, 2023Excessive Heating; Excessive Heating

  THIS IS REPORT 1 OF 2 OF THE SAME EVENT: IT WAS REPORTED FROM JAPAN THAT THE MOTOR DEVICE AND COMPACT SPEED REDUCER DEVICE WERE 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. 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 16291731 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K960630. One submission often covers many models, so check the product and lot details in each record.

• Z-1992-2017 · Oct 6, 2016 · Terminated
  Compact Speed Reducer, 60:1
• Z-1993-2017 · Oct 6, 2016 · Terminated
  Compact Speed Reducer, 60:1 Black Max
• Z-1901-2014 · Nov 28, 2012 · Terminated
  ANSPACH***REF 98-0048***Custom Circular ePLUS-FP***Rx Only*** This device is intended to be used with Anspach Systems
• Z-1900-2014 · Nov 28, 2012 · Terminated
  ANSPACH***REF 98-0044***Custom Device Speed Reducer with Bumper***Rx Only*** This device is intended to be used with Anspach Systems