NA 05.001.203Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982129659), received between Nov 29, 2017 and Feb 23, 2018 — classified as 5 malfunctions.

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

• MalfunctionFeb 23, 2018Device Operational Issue; Device Operational Issue

  THIS IS REPORT 6 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 7292758 ↗
• MalfunctionFeb 23, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THIS IS REPORT 7 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 7292748 ↗
• MalfunctionFeb 23, 2018Device Operational Issue; Device Operational Issue

  THIS IS REPORT 3 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 7292742 ↗
• MalfunctionFeb 16, 2018Difficult To Position; Difficult To Position

  IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE KNEE, IT WAS OBSERVED THAT THE BATTERY COVER (CARRIER) INSERTION SHIELD DEVICE WAS BROKEN. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO 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 Consequences Or Impact To Patient

  MAUDE report 7277907 ↗
• MalfunctionNov 29, 2017Crack; Crack

  IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE INSERTION SHIELD FOR TRAUMA RECON DEVICE WAS BROKEN. IT WAS NOT REPORTED IF THERE WERE ANY NO DELAYS TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS AVAILABLE FOR USE AND THE SURGICAL PROCEDURE WAS COMPLETED. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO 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 Consequences Or Impact To Patient

  MAUDE report 7067778 ↗