N/A 72204092Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885554033236), received between Sep 28, 2020 and Aug 9, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Corroded” (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.

• MalfunctionAug 9, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING TKA PROCEDURE, WHEN THE SPECIALIST WAS MAKING THE CUT WITH THE OSCILLATING, IN THE FEMORAL NECK, INSIDE THE PATIENT, THE OSCILLATING SAW WAS DISASSEMBLED FROM THE PORT WHERE IT RECEIVES THE BATTERY, UPON CONTACT WITH THE BONE, IT FELL APART AND NO PARTS FELL INTO THE PATIENT. THE PROCEDURE WAS FINISHED WITH A COMPETITOR DEVICE. SURGICAL DELAY LESS THAN OR EQUAL TO 30 MINUTES. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12298253 ↗
• MalfunctionSep 28, 2020Corroded; Corroded

  IT WAS REPORTED THAT THE OSCILLATING SAW HAS A UNSPECIFIED FAILURE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT. NO FURTHER INFORMATION AVAILABLE. RESULTS OF INVESTIGATION REVEALED THAT DURING VISUAL ASSESSMENT THE OSCILLATING SAW HAD INTERNAL CORROSION WHICH MAKES IT A REPORTABLE EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10592548 ↗