NA 388.113Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034771922), received between Sep 6, 2022 and Sep 6, 2022 — classified as 2 malfunctions.

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

• MalfunctionSep 6, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE INSITUBENDER TIP SNAPPED WHILE ROD BENDING DURING SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT INVOLVES ONE IN SITU BENDER-LEFT. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15363734 ↗
• MalfunctionSep 6, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE IN SITU BENDER TIP SNAPPED WHILE ROD BENDING DURING SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT INVOLVES ONE IN SITU BENDER-LEFT. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15363725 ↗