NA 05.001.227Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982130099), received between Feb 13, 2018 and Jan 18, 2022 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Fail-Safe Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 18, 2022Fail-Safe Problem; Fail-Safe Problem

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE LID DEVICE HAD A STIFF/STUCK LOCKING MECHANISM, LEAK TIGHTNESS TEST FAILURE, COMPONENT DAMAGE, DID NOT FUNCTION AND RAN IN THE LOCKED POSITION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR LEAKAGE TEST USING BUBBLE EMISSION TECHNIQUE, FUNCTION OF MODE SWITCH KNOB, CHECK THE LOCKING FUNCTION WITH HANDPIECE, CHECK IN "LOCK" MODE AND CHECK THE FUNCTION WITH THE POWER MODULE AND HANDPIECE. 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 2022. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, AN ADDITIONAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13280377 ↗
• MalfunctionSep 30, 2021Device-Device Incompatibility; Fail-Safe Did Not Operate; Device-Device Incompatibility; Fail-Safe Did Not Operate

  IT WAS REPORTED FROM THE (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE LID OF THE HANDPIECE DEVICE HAD COMPONENT DAMAGE, THE DEVICE WOULD RUN IN THE LOCKED POSITION, THE DEVICE FAILED LEAK TIGHTNESS TEST, THE LOCKING MECHANISM WAS STIFF/STUCK, AND THE LOCKING MECHANISM DID NOT FUNCTION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK IN ¿LOCK¿ MODE, CHECK FUNCTION OF THE MODE SWITCH KNOB, LEAKAGE TEST, AND CHECK THE LOCKING FUNCTION WITH THE HANDPIECE. IT WAS NOTED IN THE SERVICE ORDER THAT THE REVERSE DOES NOT WORK, AND THE LID CANNOT BE PUT ON PLACE PROPERLY. 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 12554375 ↗
• MalfunctionSep 20, 2021Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE LID DEVICE HAD LEAK TIGHTNESS TEST FAILURE, RAN IN LOCKED POSITION, LOCKING MECHANISM WAS STIFF-STUCK, COMPONENT DAMAGE AND COSMETIC DAMAGE-WORN. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, LEAKAGE TEST USING BUBBLE EMISSION TECHNIQUE, CHECK FUNCTION OF MODE SWITCH KNOB, CHECK THE LOCKING FUNCTION WITH HANDPIECE AND CHECK IN LOCK MODE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS HARD TO TURN. 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 AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12494139 ↗
• MalfunctionNov 7, 2019Unintended System Motion; Unintended System Motion

  IT WAS REPORTED FROM (B)(6) THAT DURING PRE-TESTING, IT WAS OBSERVED THAT THE LID DEVICE HAD A LID LEAK TIGHTNESS FAILURE AND CAUSED THE HAND PIECE TO RUN IN THE LOCKED POSITION. THE DEVICE ALSO FAILED PRETEST FOR CHECK THE FUNCTION WITH POWER MODULE AND HANDPIECE AND CHECK FOR LEAKAGE. THE EVENT WAS NOT RELATED TO SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2019. 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 9291958 ↗
• MalfunctionMar 22, 2018Overheating of Device; Overheating of Device

  IT WAS REPORTED FROM (B)(6) THAT THE LID FOR THE BATTERY HANDPIECE DEVICE WAS NOT WORKING AND 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 THE 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 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 Known Impact Or Consequence To Patient

  MAUDE report 7361537 ↗
• MalfunctionMar 8, 2018Unintended System Motion; Fail-Safe Problem; Unintended System Motion; Fail-Safe Problem

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE LID DEVICE WAS LEAKY. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR LEAKAGE AND CHECK THE FUNCTION WITH POWER MODULE AND HANDPIECE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNDETERMINED MALFUNCTION. 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 THIS EVENT WAS UNKNOWN. 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 7322912 ↗
• MalfunctionFeb 23, 2018Mechanical Jam; Mechanical Jam

  THIS IS REPORT 8 OF 8 FOR THE SAME EVENT: IT WAS REPORTED FROM (B)(6) THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE FEMORAL FRACTURE SURGERY, IT WAS DISCOVERED THAT THE POWER MODULE DEVICE WAS SET IN THE BATTERY HANDPIECE DEVICE USING THREE STERILE INSERTION SHIELD DEVICES; HOWEVER, THE BATTERY HANDPIECE DEVICE COULD NOT BE CLOSED WITH THREE LID DEVICES. IT WAS FURTHER REPORTED THAT SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE. IT WAS REPORTED THAT ANOTHER SET OF THE POWER MODULE DEVICE WAS SET IN AND THE LID WAS ABLE TO BE CLOSED WITHOUT ANY ISSUES. THE SURGERY WAS COMPLETED WITH A THREE MINUTE DELAY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ACCORDING TO THE REPORTER, THE SURGEON COMMENTED THAT THE SAME PHENOMENON DID NOT HAPPEN THOUGH THEY TRIED THE SAME THING AFTER THE SURGERY. 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 7292759 ↗
• MalfunctionFeb 23, 2018Mechanical Jam; Mechanical Jam

  THIS IS REPORT 4 OF 8 FOR THE SAME EVENT: IT WAS REPORTED FROM (B)(6) THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE FEMORAL FRACTURE SURGERY, IT WAS DISCOVERED THAT THE POWER MODULE DEVICE WAS SET IN THE BATTERY HANDPIECE DEVICE USING THREE STERILE INSERTION SHIELD DEVICES; HOWEVER, THE BATTERY HANDPIECE DEVICE COULD NOT BE CLOSED WITH THREE LID DEVICES. IT WAS FURTHER REPORTED THAT SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE. IT WAS REPORTED THAT ANOTHER SET OF THE POWER MODULE DEVICE WAS SET IN AND THE LID WAS ABLE TO BE CLOSE WITHOUT ANY ISSUES. THERE SURGERY WAS COMPLETED WITH A THREE MINUTE DELAY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ACCORDING TO THE REPORTER, THE SURGEON COMMENTED THAT THE SAME PHENOMENON DID NOT HAPPEN THOUGH THEY TRIED THE SAME THING AFTER THE SURGERY. 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 7292755 ↗
• MalfunctionFeb 23, 2018Mechanical Jam; Mechanical Jam

  THIS IS REPORT 5 OF 8 FOR THE SAME EVENT: IT WAS REPORTED FROM (B)(6) THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE FEMORAL FRACTURE SURGERY, IT WAS DISCOVERED THAT THE POWER MODULE DEVICE WAS SET IN THE BATTERY HANDPIECE DEVICE USING THREE STERILE INSERTION SHIELD DEVICES; HOWEVER, THE BATTERY HANDPIECE DEVICE COULD NOT BE CLOSED WITH THREE LID DEVICES. IT WAS FURTHER REPORTED THAT SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE. IT WAS REPORTED THAT ANOTHER SET OF THE POWER MODULE DEVICE WAS SET IN AND THE LID WAS ABLE TO BE CLOSE WITHOUT ANY ISSUES. THERE SURGERY WAS COMPLETED WITH A THREE MINUTE DELAY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ACCORDING TO THE REPORTER, THE SURGEON COMMENTED THAT THE SAME PHENOMENON DID NOT HAPPEN THOUGH THEY TRIED THE SAME THING AFTER THE SURGERY. 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 7292752 ↗
• MalfunctionFeb 14, 2018Unintended System Motion; Overheating of Device; Fail-Safe Problem; Unintended System Motion; Overheating of Device; Fail-Safe Problem

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE LID FOR THE HANDPIECE DEVICE TURNING KNOB WAS BLOCKED AND DUE TO A BURNING EFFECT MOST OF THE PARTS WERE DAMAGED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK STATUS OF DEVELOPMENT, GENERAL CONDITION, CHECK FUNCTION OF TURNING KNOB, CHECK FUNCTION ¿LOCK/UNLOCK¿ WITH SAFETY PIN, CHECK THE LOCKING FUNCTION WITH HAND PIECE AND CHECK THE FUNCTION WITH POWER MODULE AND HANDPIECE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNSPECIFIED MALFUNCTION. 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 BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7269946 ↗
• MalfunctionFeb 13, 2018Unintended System Motion; Fail-Safe Problem; Unintended System Motion; Fail-Safe Problem

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE LID DEVICE WAS LEAKY. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR LEAKAGE AND CHECK FUNCTION ¿LOCK/UNLOCK¿ WITH SAFETY PIN. 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 AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7268379 ↗