N/A 01-3905Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841036011222), received between Jul 26, 2019 and Jan 5, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2021Fracture; Fracture

  IT WAS REPORTED THE CLASP FRACTURED OFF THE PECTUS BAR BENDER DURING SURGERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER PRODUCT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11121468 ↗
• MalfunctionAug 24, 2020Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT DISASSEMBLED DURING A PECTUS BAR REMOVAL PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT THE USE OF THE INSTRUMENT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10442464 ↗
• MalfunctionJun 29, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10209004 ↗
• InjuryJan 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PECTUS BAR BENDER WAS UNABLE TO FUNCTION DURING SURGERY. THERE WAS A NINETY MINUTE DELAY WHILE A NEW INSTRUMENT WAS PROCURED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9596226 ↗
• MalfunctionJul 26, 2019Fracture; Fracture

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8832785 ↗