NA 05.001.202Recalls & reported problems

Summary

The FDA's MAUDE database contains 263 adverse event reports that list this exact device (DI 10886982129635), received between Nov 22, 2017 and Sep 28, 2026 — classified as 263 malfunctions.

The most frequently reported specific device problem is “Complete Loss of Power” (122 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 263 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Complete Loss of Power

  It was reported that the POWER MODULE FOR TRAUMA RECON SYSTEM device stopped working while in use with 2X battery handpiece devices, the chuck with key device, the quick coupling device and the ao reamer device. The user did not know whether the system was working or not. It was not reported if the device was used in surgery. 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 50920487 ↗
• MalfunctionSep 15, 2026Leak/Splash

  It was reported that during service and evaluation, it was determined that the power module device was leaking liquid, had fluid ingress, and would not charge. It was further determined that the device failed pretest for Information button and Self-test, Charging and checking of Power module in universal battery charger (UBC II), and Check Liquid Indicator. 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 2026. 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 50772869 ↗
• MalfunctionAug 12, 2026Leak/Splash; Complete Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50226567 ↗
• MalfunctionJul 9, 2026Leak/Splash; Complete Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25761985 ↗
• MalfunctionJul 7, 2026Leak/Splash; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE POWER MODULE FOR TRAUMA RECON SYSTEM DEVICE WAS LEAKING A LIQUID. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DOES NOT WORK. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25737130 ↗
• MalfunctionJul 6, 2026Leak/Splash; Output below Specifications

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE POWER MODULE DEVICE HAD A LIQUID LEAK. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD LOW POWER. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 25715752 ↗
• MalfunctionJul 1, 2026Leak/Splash

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE POWER MODULE DEVICE HAD A LIQUID LEAK. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNDETERMINED MALFUNCTION. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 25677579 ↗
• MalfunctionJun 3, 2026Leak/Splash; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE POWER MODULE DEVICE HAD A LIQUID LEAK. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. 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 25377119 ↗
• MalfunctionMay 26, 2026Leak/Splash; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE POWER MODULE FOR TRAUMA RECON SYSTEM DEVICE WAS LEAKING A LIQUID. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. 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 25279053 ↗
• MalfunctionMay 18, 2026Leak/Splash; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE POWER MODULE FOR TRAUMA RECON SYSTEM DEVICE WAS LEAKING A LIQUID. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. 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 25200275 ↗
• MalfunctionApr 27, 2026Leak/Splash; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE POWER MODULE DEVICE HAD A LIQUID LEAK. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 24999659 ↗
• MalfunctionApr 13, 2026Leak/Splash; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE POWER MODULE DEVICE HAD A LIQUID LEAK. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. 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 24860594 ↗
• MalfunctionApr 7, 2026Leak/Splash

  IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS DISCOVERED THAT THE POWER MODULE DEVICE HAD A LIQUID LEAK. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 24799474 ↗
• MalfunctionApr 7, 2026Leak/Splash

  IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS DISCOVERED THAT THE POWER MODULE DEVICE HAD A LIQUID LEAK. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 24799439 ↗
• MalfunctionMar 6, 2026Leak/Splash

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE POWER MODULE DEVICE HAD A LIQUID LEAK. 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 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531609 ↗
• MalfunctionMar 6, 2026Fail-Safe Did Not Operate

  IT WAS REPORTED THAT THE POWER MODULE FOR TRAUMA RECON SYSTEM DEVICE DISPLAYED AN LED WARNING LIGHT INDICATOR ERROR. 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 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531346 ↗
• MalfunctionMar 5, 2026Leak/Splash; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE POWER MODULE DEVICE WAS LEAKING A LIQUID. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNDETERMINED MALFUNCTION. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24527526 ↗
• MalfunctionMar 5, 2026Leak/Splash; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE POWER MODULE DEVICE WAS LEAKING A LIQUID. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNDETERMINED MALFUNCTION. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24527490 ↗
• MalfunctionMar 5, 2026Leak/Splash

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE POWER MODULE DEVICE HAD A FLUID LEAK. 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 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519688 ↗
• MalfunctionMar 3, 2026Leak/Splash; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE POWER MODULE DEVICE WAS LEAKING A LIQUID. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN, BUT WAS KNOWN TO HAVE OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24495352 ↗
• MalfunctionFeb 20, 2026Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE POWER MODULE DEVICE WOULD NOT CHARGE AND WAS LEAKING LIQUID. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR INFORMATION BUTTON AND SELF-TEST, CHARGING AND CHECKING OF POWER MODULE IN CHARGER UBC, FUNCTION ¿ TEST, SAW TEST, AND CHECK LIQUID INDICATOR. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 24405673 ↗
• MalfunctionFeb 20, 2026Leak/Splash

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE POWER MODULE DEVICE WAS LEAKING LIQUID. 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 24402561 ↗
• MalfunctionFeb 18, 2026Leak/Splash; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE POWER MODULE DEVICE WAS LEAKING A LIQUID. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. 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 24377109 ↗
• MalfunctionFeb 18, 2026Leak/Splash; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE POWER MODULE DEVICE WAS LEAKING A LIQUID. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. 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 24377049 ↗
• MalfunctionFeb 18, 2026Leak/Splash; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE POWER MODULE DEVICE WAS LEAKING A LIQUID. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. 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 24376954 ↗