NA 532.015Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982240477), received between Dec 16, 2020 and May 16, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Complete Loss of Power” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2024Device-Device Incompatibility; Complete Loss of Power; Device-Device Incompatibility; Complete Loss of Power

  IT WAS REPORTED THAT THE QUICK COUPLING DEVICE WAS NOT WORKING. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE DEVICE HAD UNINTENDED/UNEXPECTED DISENGAGEMENT. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 19336867 ↗
• MalfunctionJun 1, 2023Premature Separation; Premature Separation

  THIS IS REPORT 2 OF 2 OF THE SAME EVENT IT WAS REPORTED FROM UNITED KINGDOM THAT THE LARGE QUICK COUPLING DEVICE WAS DEPOSITING METAL FRAGMENTS WHILE IN USE WITH THE RECIPROCATING SAW ATTACHMENT DEVICE AND TWO QUICK COUPLING FOR K WIRES DEVICES. DURING FURTHER FOLLOW UP WITH THE REPORTER IT WAS REPORTED THAT THERE WERE TINY PARTICLES OF WHAT LOOKED LIKE METAL COMING OUT OF IT. THIS ONLY HAPPENED WHEN THE SWITCH WAS ON. NOTHING FELL OUT OF IT OTHERWISE. THE USER TRIED TO PLACE A WHITE PAPER OVER A SHEET OF WHITE PAPER AND IT SMEARED A GREY/BLACK POWDER OR DUST OVER THE PAPER. THERE WAS NO OBVIOUS DAMAGE TO THE OUTSIDE OF THE DEVICE. THE REPORTER WAS UNSURE WHETHER A PART OF THE K WIRE HAD BEEN BROKEN OFF INSIDE THE QUICK COUPLING BECAUSE IT WAS GRINDING UP. 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17039694 ↗
• MalfunctionDec 16, 2020Device Slipped; Detachment of Device or Device Component; Device Slipped; Detachment of Device or Device Component

  IT WAS REPORTED FROM (B)(6) THAT THE BASE OF THE TRIPLE REAMER ATTACHMENT DEVICE COULD BE UNSCREWED AND THE GEAR WAS LOOSE. 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 EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2020. 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 11023168 ↗