NA 05.001.183Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982129567), received between Aug 31, 2018 and Feb 20, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Complete Loss of Power” (2 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2025Appropriate Device Problem Term/Code Not Available; Noise, Audible; Excessive Heating; Appropriate Device Problem Term/Code Not Available; Noise, Audible; Excessive Heating

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAW ATTACHMENT DEVICE HAD EXCESSIVE NOISE, HEAT AND THE MOVING PARTS DID NOT MOVE SMOOTHLY. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK GENERAL FUNCTION IN THE RUNNING MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS RATTLING WHEN IN USE. 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 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 21426030 ↗
• MalfunctionMay 24, 2024Material Fragmentation; Complete Loss of Power; Material Fragmentation; Complete Loss of Power

  IT WAS REPORTED THAT DURING AN OSTEOTOMY PROCEDURE IT WAS OBSERVED THAT THE SAW BLADE OSCILLATION STOPPED AS SOON AS PRESSURE WAS APPLIED, AND SMALL AMOUNTS OF DEBRIS WERE NOTED SIMULTANEOUSLY. 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 PATIENT INVOLVEMENT REPORTED 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 19397178 ↗
• MalfunctionMay 24, 2024Material Fragmentation; Complete Loss of Power; Material Fragmentation; Complete Loss of Power

  IT WAS REPORTED THAT DURING AN OSTEOTOMY PROCEDURE IT WAS OBSERVED THAT THE SAW BLADE OSCILLATION STOPPED AS SOON AS PRESSURE WAS APPLIED, AND SMALL AMOUNTS OF DEBRIS WERE NOTED SIMULTANEOUSLY. 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 PATIENT INVOLVEMENT REPORTED 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 19397098 ↗
• MalfunctionAug 31, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE COUPLING TOOL SIDE OF THE SAW ATTACHMENT/IN-LINE DEVICE WAS BROKEN AND TORN OFF. IT WAS FURTHER DETERMINED THAT THE SAW HEAD BASE WAS BROKEN. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR STEEL HOUSING VERSION, TICK ¿PASS¿ FOR STEEL HOUSING AND CHECK THE SAW BLADE COUPLING. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK ANYMORE. 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 2018. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7838546 ↗