V. Mueller CH1290Recalls & reported problems
Steris Corporation · V. Mueller TITANIUM ANKENEY STERNAL RETR BLADE 1-1/4 X1-3/8 inches 3.2 X3.5CM, ARM LENGTH 11-1/2 inches 29.2CM, SPREAD 7 inches 17.8CM · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403023705), received between Sep 4, 2024 and Oct 15, 2024 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
ON (B)(6) 2024, AVALIGN GSI QUALITY RECEIVED A CUSTOMER COMPLAINT FROM STERIS. STERIS REPORTED THAT THEY RECEIVED A COMPLAINT FROM THE HOSPITAL STATING, PRODUCT SNAPPED IN HALF OVER PATIENT ON TABLE DURING HEART PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20451632 ↗MalfunctionSep 4, 2024Break; Break
THE USER FACILITY REPORTED THAT DURING A HEART PROCEDURE THE TITANIUM ANKENEY STERNAL BLADE BROKE IN HALF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DIFFERENT INSTRUMENT. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20137734 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.