NA 532.018Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982240521), received between Jan 23, 2018 and Jul 14, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Inoperable” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2021Device-Device Incompatibility; Premature Separation; Device-Device Incompatibility; Premature Separation

  IT WAS REPORTED FROM (B)(6) THAT DURING SURGERY FOR A FEMORAL FRACTURE, IT WAS DISCOVERED THAT THE REDUCTION DRIVE DEVICE FAILED TO LOCK ONTO THE HANDPIECE DEVICE AND FELL OUT EASILY. IT WAS FURTHER REPORTED THAT THE SURGEON CONTINUED TO USE THE UNLOCKED DEVICES TO COMPLETE THE SURGERY WITHOUT ANY SURGICAL DELAY. IT WAS NOTED THAT ANOTHER ATTACHMENT DEVICE WAS ATTACHED TO THE HANDPIECE DEVICE WITHOUT ISSUE AND THE PROBLEM SEEMED TO BE WITH THE REDUCTION DRIVE DEVICE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12167196 ↗
• MalfunctionJan 23, 2018Device Inoperable; Device Operates Differently Than Expected; Device Inoperable; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE HIP IT WAS OBSERVED THAT THE REDUCTION DRIVE DEVICE WOULD NOT GO IN REVERSE. IT WAS REPORTED THAT THERE WAS NO DELAY IN THE PROCEDURE DUE TO THE EVENT WAS AN UNSPECIFIED SPARE DEVICE WAS 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 Consequences Or Impact To Patient

  MAUDE report 7212965 ↗