NA 359.207Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982197085), received between Jul 23, 2019 and Sep 1, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM BELGIUM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, TWO DEVICES WERE DELIVERED WITH WEAR AND TEAR. FOLLOWING THE PROCEDURE, BOTH DEVICES WERE NO LONGER USABLE. PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A BAR FOR SMALL F-TOOL. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15338032 ↗
• MalfunctionJul 23, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, THE THREADS OF A BAR FOR F-TOOL AND THREADED ROD FOR F-TOOL BROKE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8815867 ↗