NA 532.026Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 10886982240651), received between Feb 12, 2019 and Aug 31, 2026 — classified as 70 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (19 reports).

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 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Device Slipped; Premature Separation

  It was reported that during service and evaluation, it was determined that the oscillating saw attachment device had an unintended/unexpected disengagement. It was noted in the service order that during an unspecified surgical procedure, it was discovered that when the "TPLO" attachment was connected to the UNIUM handpiece and operated, the attachment's locking mechanism rotated and became loose by itself. It was not reported if there were any delays in the 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 50531154 ↗
• MalfunctionAug 3, 2026Device Slipped; Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50117848 ↗
• MalfunctionFeb 9, 2026Complete Loss of Power; Premature Separation

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAW ATTACHMENT DEVICE HAD UNINTENDED/UNEXPECTED DISENGAGEMENT. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING PROPERLY. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THIS DEVICE IS INTENDED FOR VETERINARY PURPOSES. 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 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299020 ↗
• MalfunctionDec 17, 2025Device-Device Incompatibility; Premature Separation; Device-Device Incompatibility; Premature Separation

  IT WAS REPORTED THAT THE SAW ATTACHMENT DEVICE BECAME UNATTACHED WHEN TRYING TO RUN IT. THE LOCK WAS TWISTED ON WHEN WE RAN THE SAW. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THE FACILITY IS A VETERINARY MEDICAL HOSPITAL, AND THEREFORE, THE DEVICE IS MOST LIKELY USED FOR VETERINARY PURPOSES ONLY. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828709 ↗
• MalfunctionNov 12, 2025Break; Material Fragmentation; Device-Device Incompatibility; Excessive Heating; Break; Material Fragmentation; Device-Device Incompatibility; Excessive Heating

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT ONE SIDE OF THE DRILL BLADE¿S CONNECTION TO THE ATTACHMENT DEVICE WAS COMPLETELY DAMAGED, MAKING INSTALLATION IMPOSSIBLE IT WAS REPORTED THAT THE DAMAGE PREVENTED THE DEVICE FROM BEING SECURELY FIXED. IT WAS FURTHER REPORTED THAT THE DEVICE TENDED TO OVERHEAT DURING 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 23534746 ↗
• MalfunctionOct 15, 2025Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE OSCILLATING SAW ATTACHMENT DEVICE METAL TIP DESIGNED TO HOLD THE SAW BLADE BROKE. WHEN THE BLADE WAS DISASSEMBLED, THE BROKEN PIECE OF METAL DETACHED AND FELL OFF. 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 23277946 ↗
• MalfunctionSep 8, 2025Device Slipped; Appropriate Device Problem Term/Code Not Available; Device Slipped; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE OSCILLATING SAW ATTACHMENT DEVICE WAS SPINNING. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT DEVICE (2+ DEVICES) HAD UNINTENDED/UNEXPECTED DISENGAGEMENT, HAD COMPONENT DAMAGE AND DID NOT FUNCTION. THE DEVICE ALSO FAILED PRETESTS FOR GENERAL CONDITION, CHECK FUNCTION OF LOCKING MECHANISM AND CHECK OSCILLATION FREQUENCY WITH FREQUENCY METER. 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 22993441 ↗
• MalfunctionSep 3, 2025Mechanical Jam; Premature Separation; Mechanical Jam; Premature Separation

  IT WAS REPORTED THAT THE OSCILLATING SAW ATCH, LARGE, WITH KEY DEVICE DETACHED ITSELF FROM THE MOTOR DEVICE. HOWEVER, THE DEVICE DID NOT MOVE WHEN ATTACHED TO THE MOTOR DEVICE. 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 FOR USE. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THIS DEVICE IS INTENDED FOR VETERINARY PURPOSES. 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 22952946 ↗
• MalfunctionMay 2, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE SAW ATTACHMENT WOULD UNLOCK WHEN THE HANDPIECE/DRILL DEVICE WAS POWERED ON. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN A SURGICAL PROCEDURE. IT WAS NOT REPORTED IF THERE WAS DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE 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 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 21952064 ↗
• MalfunctionApr 3, 2025Complete Loss of Power; Excessive Heating; Complete Loss of Power; Excessive Heating

  IT WAS REPORTED THAT THE ATTACHMENT DEVICE DID NOT OPERATE WHEN CONNECTED TO THE HANDPIECE DEVICE AND THE ATTACHMENT WOULD RAPIDLY OVERHEAT. IT WAS REPORTED THAT THE HANDPIECE WORKS PROPERLY WHEN CONNECTED TO OTHER ATTACHMENTS. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. 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 21767107 ↗
• MalfunctionMar 31, 2025Detachment of Device or Device Component; Mechanical Jam; Separation Problem; Detachment of Device or Device Component; Mechanical Jam; Separation Problem

  IT WAS REPORTED THAT THE SAW ATTACHMENT DEVICE, WHEN CONNECTING THE ATTACHMENT AND SAW AND PROCEEDING WITH THE "LOCKING," A BREAKAGE OCCURRED AT THE END OF THE STAR DRIVE (THE PART THAT BEARS A LOT OF FORCE WHEN SECURING THE ATTACHMENT AND SAW). FRAGMENTS FROM THE BREAKAGE ARE LODGED IN THE ATTACHMENT, MAKING IT IMPOSSIBLE TO DETACH AND SEPARATE THE SAW. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21730808 ↗
• MalfunctionMar 25, 2025Device Slipped; Premature Separation; Device Slipped; Premature Separation

  IT WAS REPORTED THAT DURING A TIBIAL PLATEAU LEVELING OSTEOTOMY (TPLO) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE TIGHTENING 'CHUCK' ON THE SAW ATTACHMENT DEVICE COMES LOOSE DURING THE PROCEDURE. IT WAS NOTED THAT THE BLADE WAS SECURE, JUST THE ATTACHMENT ON THE HANDPIECE WAS LOOSE. IT WAS FURTHER OBSERVED THAT THE HANDPIECE DEVICE HAD VERY SLOW REVERSE SPEED. IT WAS NOT REPORTED IF THERE WAS DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE AVAILABLE FOR USE. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THIS WAS A VETERINARY PROCEDURE. 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 21687331 ↗
• MalfunctionJan 30, 2025Complete Loss of Power; Fail-Safe Did Not Operate; Complete Loss of Power; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT THE DEVICE WAS LOCKED AND KEPT SPINNING ON THE DRILL. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THE DEVICE WAS FOR VETERINARY USE ONLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21277637 ↗
• MalfunctionOct 24, 2024Complete Loss of Power; Excessive Heating; Complete Loss of Power; Excessive Heating

  IT WAS REPORTED FROM FRANCE THAT DURING AN UNSPECIFIED VETERINARY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE OSCILLATING SAW ATTACHMENT DEVICE LACKED POWER, HEATED UP AND MADE CUTTING DIFFICULT. 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 HUMAN PATIENT INVOLVEMENT AS THIS DEVICE IS INTENDED FOR VETERINARY PURPOSES. 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 20522654 ↗
• MalfunctionOct 24, 2024Premature Separation; Premature Separation

  IT WAS REPORTED FROM THE NETHERLANDS THAT THE OSCILLATING SAW ATTACHMENT DEVICE DETACHED ITSELF FROM THE HANDPIECE DEVICE DURING USE. 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 20520639 ↗
• MalfunctionOct 9, 2024Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SURGERY IT WAS OBSERVED THAT THE PART OF OSCILLATING SAW ATTACHMENT DEVICE WHERE BLADE GETS SCREWED HAD BROKEN OFF. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS OBSERVED THAT THE DEVICE HAD FRACTURED COUPLING AND COMPONENT DAMAGE. IT WAS FURTHER DETERMINED THAT THE DEVICE FELL APART AND BECAME UNATTACHED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK GEOMETRY OF SAW BLADE COUPLING, CHECK SAW BLADE COUPLING, AND CHECK OSCILLATION FREQUENCY WITH FREQUENCY METER. 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 20410449 ↗
• MalfunctionSep 27, 2024Device Slipped; Detachment of Device or Device Component; Device-Device Incompatibility; Device Slipped; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE OSCILLATING SAW ATTACHMENT DEVICE HAD THE FOLLOWING FAILURES: FELL APART - UNATTACHED AND DOES NOT FUNCTION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST ON THE FOLLOWING: GENERAL CONDITION, CHECK FUNCTION OF LOCKING MECHANISM AND CHECK OSCILLATION FREQUENCY WITH FREQUENCY METER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT LOCK IN PLACE AND WOULD CONTINUOUSLY SPIN. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THE DEVICE WAS FOR VETERINARY USE ONLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20320530 ↗
• MalfunctionJun 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED VETERINARY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE OSCILLATING SAW ATTACHMENT DEVICE CAME OFF OF THE DRILL WITHOUT UNLOCKING IT. 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 HUMAN PATIENT INVOLVEMENT AS THIS WAS A VETERINARY PROCEDURE. 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 19604423 ↗
• MalfunctionJun 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY NORWAY THAT DURING AN UNSPECIFIED VETERINARY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE OSCILLATING SAW ATTACHMENT DEVICE TIP FELL OFF. IT WAS REPORTED THAT THERE WERE NO DELAYS AND A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THIS WAS A VETERINARY PROCEDURE. 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 19509075 ↗
• MalfunctionMay 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT FOLLOWING AN UNSPECIFIED VETERINARY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE OSCILLATING SAW ATTACHMENT DEVICE TOP WHERE THE BLADE IS SCREWED ON WAS SPLIT. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THIS WAS A VETERINARY PROCEDURE. 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 19307850 ↗
• MalfunctionApr 18, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED VETERINARY SURGICAL PROCEDURE IT WAS OBSERVED THAT WHEN THE ATTACHMENT DEVICE WAS USED WITH THE SMALL BATTERY DRIVE DEVICE AND PRESSURE LOAD WAS APPLIED, THE ATTACHMENT DEVICE WOULD INTERMITTENTLY LOSE ENGAGEMENT AND WOULD NOT COMPLETE THE CUT. 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 NO HUMAN PATIENT INVOLVEMENT AS THIS WAS A VETERINARY PROCEDURE. 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 19137891 ↗
• MalfunctionJan 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY NETHERLANDS THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE OSCILLATING SAW ATTACHMENT DEVICE FELL APART ¿ UNATTACHED. IT WAS DETERMINED THAT THE DEVICE HAD COMPONENT DAMAGE, DID NOT FUNCTION AND THE ATTACHMENT COULD NOT BE ENGAGED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK FUNCTION OF LOCKING MECHANISM, CHECK HANDPIECE COUPLING AND CHECK OSCILLATION FREQUENCY WITH FREQUENCY METER. 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 18496294 ↗
• MalfunctionDec 19, 2023Noise, Audible; Excessive Heating; Noise, Audible; Excessive Heating

  IT WAS REPORTED FROM THE UNITED KINGDOM THAT THE OSCILLATING SAW ATTACHMENT DEVICE WAS LOUD AND PRODUCED AN UNUSUAL NOISE WHEN IN USE CAUSING OVERHEATING OF THE DEVICE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THIS DEVICE WAS INTENDED FOR VETERINARY USE ONLY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356390 ↗
• MalfunctionNov 20, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED FROM CANADA THAT THE SAW ATTACHMENT DEVICE HAD AN OIL SUBSTANCE LEAKING FROM IT DURING USE. 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 2023. 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 18170561 ↗
• MalfunctionNov 14, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM FRANCE THAT THE OSCILLATING SAW ATTACHMENT DEVICE 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. 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 18132126 ↗