NA 511.761Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982237729), received between Apr 20, 2021 and Dec 5, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2022Leak/Splash; Device-Device Incompatibility; Leak/Splash; Device-Device Incompatibility

  IT WAS REPORTED FROM FRANCE THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE QUICK COUPLING DEVICE WAS NOT COUPLED TO THE COMPACT MOTOR AND HAD WATER LEAK WHEN USING RIA. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15913620 ↗
• MalfunctionAug 12, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, WHEN MOUNTING THE RIA SYSTEM, THE TRIPLE-MILLING ADAPTER WAS LACKING THE INTERNAL NOTCH, WHICH MEANS THAT IT WOULD NOT COUPLE TO THE TRANSMISSION SHAFT AND DOES NOT ROTATE. PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO PATIENT IMPACT. THIS REPORT IS FOR A LARGE QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12314615 ↗
• MalfunctionJul 9, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE QUICK COUPLING DEVICE ADAPTOR STOPPED WORKING THE CAD PERFORATOR DURING THE PROCEDURE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR WHETHER 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12142609 ↗
• MalfunctionApr 20, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, DURING THE LOAN KIT INSPECTION A PIECE OF THE COUPLING REAMER SNAPPED OFF. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. THIS REPORT IS FOR ONE (1) LARGE QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11692430 ↗