NA 511.902Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982238078), received between Jul 17, 2020 and Jul 22, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Complete Loss of Power” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2024Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED FROM NETHERLANDS THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE RECIPROCATOR SAW ATTACHMENT DEVICE WAS FROZEN (WOULD NOT MOVE). IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETESTS FOR CHECK FUNCTION IN RUNNING MODE AND CHECK THE OSCILLATION FREQUENCY WITH FREQUENCY METER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DOES NOT WORK AT ALL DURING ROUTINE MAINTENANCE. 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 19793180 ↗
• MalfunctionOct 5, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM NETHERLANDS THAT DURING SERVICE AND REPAIR/PRE-TESTING, IT WAS OBSERVED THAT THE RECIPROCATING SAW ATTACHMENT DEVICE HEATED UP, WAS VIBRATING AND HE MOVING PARTS DID NOT MOVE SMOOTHLY. THE DEVICE ALSO FAILED PRETESTS FOR FUNCTION IN RUNNING MODE AND 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 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 17876476 ↗
• MalfunctionApr 26, 2023Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED BY RUSSIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE RECIPROCATING SAW ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE. IT WAS OBSERVED THAT THE DEVICE HAD A COSMETIC DAMAGE ¿ WORN ETCH, AND THE LABELING HAD AN ILLEGIBLE ETCH. IT WAS FURTHER DETERMINED THAT THE DEVICE COULD NOT ENGAGE THE ATTACHMENT ¿ COUPLING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, MARKING AND LABELING, CHECK THE HANDPIECE COUPLING, CHECK SYMMETRY WITH HANDPIECE, CHECK FUNCTION IN RUNNING MODE AND CHECK THE OSCILLATION FREQUENCY WITH FREQUENCY METER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. IT WAS REPORTED THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AND THE SURGERY WAS COMPLETED AS INTENDED. IT IS UNKNOWN IF THERE WAS 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 16815768 ↗
• MalfunctionApr 22, 2022Mechanical Jam; Complete Loss of Power; Mechanical Jam; Complete Loss of Power

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE WAS FROZEN/WOULD NOT MOVE, AND DID NOT FUNCTION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK THE HANDPIECE COUPLING, CHECK SYMMETRY WITH THE HANDPIECE, CHECK FUNCTION IN RUNNING MODE, AND CHECK OSCILLATION FREQUENCY. IT WAS NOTED IN THE SERVICE ORDER THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT WHEN THE DEVICE MADE CONTACT WITH BONE, IT WOULD LOSE STRENGTH. 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 (B)(6) OF 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 14188359 ↗
• MalfunctionJul 17, 2020Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BEARING OF THE ATTACHMENT DEVICE WAS WORN OUT AND CORRODED, THE MOVING PARTS OF THE DEVICE DID NOT MOVE SMOOTHLY, AND THERE WAS HEAT. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR HEAT, AND CHECK OSCILLATION FREQUENCY. 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 NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2020. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10289927 ↗