NA 332.09Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982192523), received between Dec 6, 2019 and Jul 28, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Corroded” (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. 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.

• MalfunctionJul 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS A NARROW PASS WAY DOESN'T ALLOW CHISEL TO FOLLOW THROUGH. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT IS FOR ONE CHISEL GUIDE WITH ADJUSTABLE ANGLE FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17414163 ↗
• 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) CHISEL GUIDE WITH ADJUSTABLE ANGLE. THIS REPORT IS 5 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12091746 ↗
• 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 2 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12036397 ↗
• MalfunctionApr 9, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, A CHISEL BECAME STUCK IN THE GUIDE. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A CHISEL GUIDE WITH ADJUSTABLE ANGLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11641128 ↗
• MalfunctionDec 6, 2019Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, TWO INSTRUMENTS WERE BROKEN. IT IS UNKNOWN HOW THE DISCOVERY TOOK PLACE. THERE IS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A CHISEL GUIDE WITH ADJUSTABLE ANGLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9432655 ↗