NA 530.690Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982240118), received between Dec 21, 2017 and Oct 4, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2024Physical Resistance/Sticking; Complete Loss of Power; Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED FROM RUSSIA THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE MOTOR WOULD NOT RUN, THE ELECTRICAL CONTROL UNIT DAMAGED, THE TRIGGER MOVING PARTS DID NOT MOVE SMOOTHLY AND MODE SWITCH RESISTANCE WAS TOO HIGH. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETESTS FOR CHECK FOR STICKY TRIGGER, CHECK OSCILLATION FREQUENCY WITH FREQUENCY METER AND MODE SWITCH-TEST. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WILL NOT RUN. 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 20372441 ↗
• MalfunctionAug 8, 2023Premature Separation; Premature Separation

  IT WAS REPORTED FROM JAPAN THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) FOR OSTEOARTHRITIS (OA) OF THE KNEE IT WAS OBSERVED THAT WHEN THE BATTERY CASING FOR THE BATTERY POWER LINE WAS CLOSED AFTER BATTERY INSERTION, THE LOCK OF THE PRODUCT IN QUESTION WAS RELEASED. IT WAS REPORTED THAT THERE WAS NO DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE 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 17482202 ↗
• MalfunctionJun 24, 2021Device-Device Incompatibility; Premature Separation; Device-Device Incompatibility; Premature Separation

  IT WAS REPORTED FROM (B)(6) THAT THE BATTERY CASING DEVICE WAS BROKEN. IT WAS FURTHER REPORTED THAT THE CASE WAS NOT LOCKING INTO THE BATTERY COMPARTMENT ON THE HANDPIECE DEVICE AND WAS FALLING OUT 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. 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 2021. 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 12062055 ↗
• MalfunctionJun 11, 2021Device-Device Incompatibility; Premature Separation; Device-Device Incompatibility; Premature Separation

  IT WAS REPORTED FROM (B)(6) THAT THE BATTERY CASING DEVICE WAS BROKEN. IT WAS FURTHER REPORTED THAT THE CASE WAS NOT LOCKING INTO THE BATTERY COMPARTMENT ON THE HANDPIECE DEVICE AND WAS FALLING OUT 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. 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 2021. 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 11985280 ↗
• MalfunctionDec 10, 2019Premature Separation; Premature Separation

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY CASING DEVICE FRACTURED. IT WAS NOTED THAT THE LOCKING LEVER WAS RELEASED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK LEAKAGE, AND CHECK CASING LOCKS. 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 NOT REPORTED. 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 9444435 ↗
• MalfunctionJan 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BATTERY CASING DEVICE CONNECTOR PRONGS WERE TOO SHORT TO FULLY CONNECT WITH THE BATTERY POWER LINE HANDPIECE AND THE DEVICE VIBRATES OUT OF CONNECTION WHEN THE SYSTEM WAS BEING RAN. 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 IS UNKNOWN. ALL AVAILABLE HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION WERE TO BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8278205 ↗
• MalfunctionDec 21, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT: IT WAS REPORTED FROM (B)(6) THAT DURING A KNEE OSTEOARTHRITIS (LEFT SIDE) SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE BATTERY REAMER/DRILL DEVICE SUDDENLY STOPPED WORKING WHEN USED TOGETHER WITH THE BATTERY CASING DEVICE. IT WAS REPORTED THAT THE EVENT OCCURRED DURING USE ON A PATIENT. THERE WAS A TWENTY MINUTE DELAY TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE. 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 Consequences Or Impact To Patient

  MAUDE report 7139985 ↗