NA 332.121Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982192561), received between Nov 10, 2020 and Jan 22, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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. How this data works · Data updated Oct 13, 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 22, 2024Material Deformation; Material Deformation

  THE NAIL REMOVAL SURGERY WAS BEING PERFORMED DUE TO A NON-UNION. THE HAMMER GUIDE THREADED INTO EXTRACTOR AND CROSS THREADED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18557177 ↗
• MalfunctionJun 30, 2021Corroded; Material Deformation; Corroded; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. DURING THE PROCEDURE, TWO DEPTH GAUGE TIPS WERE BENT AND BROKEN. EIGHT THREADED DRILL GUIDE, FOUR DRILL BIT, TWO END CAP, TWO CANNULATED CHISEL, TWO CHISEL GUIDE, AND LOCKING COMPRESSION PLATE (LCP) PROXIMAL HUMERUS PLATE HAD WERE INVOLVED IN THREADS STRIPPING VA LOCKING HOLES. CHISEL AND GUIDE WERE BENT DURING PROCESS OF INSERTION. NO FRAGMENTS WERE GENERATED. THERE WAS A SURGICAL DELAY OF FIVE MINUTES. PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR (1) CANN CHISEL FOR ADULT ANGD BLADE PLS 320. THIS REPORT IS 6 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12091752 ↗
• MalfunctionJun 21, 2021Corroded; Material Deformation; Corroded; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. DURING THE PROCEDURE, TWO DEPTH GAUGE TIPS WERE BENT AND BROKEN. EIGHT THREADED DRILL GUIDE, FOUR DRILL BIT, TWO END CAP, TWO CANNULATED CHISEL, TWO CHISEL GUIDE, AND LOCKING COMPRESSION PLATE (LCP) PROXIMAL HUMERUS PLATE HAD WERE INVOLVED IN THREADS STRIPPING VA LOCKING HOLES. CHISEL AND GUIDE WERE BENT DURING PROCESS OF INSERTION. NO FRAGMENTS WERE GENERATED. THERE WAS A SURGICAL DELAY OF FIVE MINUTES. PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCE. THIS REPORT IS 1 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12036472 ↗
• MalfunctionNov 10, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2020, PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF RIGHT FEMUR WITH ANGLE BLADE PLATES. DURING THE PROCEDURE, TWO (2) CANNULATED CHISELS FOR ADULT ANGLED BLADE PLATES WERE BENT. SURGERY WAS DELAYED FOR ABOUT FIVE (5) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS UNKNOWN. THIS REPORT IS FOR ONE (1) CANNULATED CHISEL FOR ADULT ANGLED BLADE PLATES 320MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10817624 ↗
• MalfunctionNov 10, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2020, PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF RIGHT FEMUR WITH ANGLE BLADE PLATES. DURING THE PROCEDURE, TWO (2) CANNULATED CHISELS FOR ADULT ANGLED BLADE PLATES WERE BENT. SURGERY WAS DELAYED FOR ABOUT FIVE (5) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS UNKNOWN. THIS REPORT IS FOR ONE (1) CANNULATED CHISEL FOR ADULT ANGLED BLADE PLATES 320MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10817621 ↗