NA 03.133.101Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886982269607), received between Apr 1, 2021 and May 15, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (11 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Break

  DURING THE PROCEDURE, IT WAS OBSERVED THAT WHEN THE SPECIALIST USED THE 2.0MM CALIBRATED DRILL BIT, TO DRILL AND MEASURE A HOLE, THE BIT BROKE AT THE TIP AS THE DRILLING BEGAN. A PROMPT SOLUTION WAS IMPLEMENTED BY REMOVING THE BROKEN BIT AND REPLACING IT WITH ANOTHER OF THE SAME SPECIFICATIONS, ALSO INCLUDED IN THE KIT. THIS ALLOWED THE SURGERY TO BE COMPLETED SUCCESSFULLY WITHOUT ANY ADVERSE EFFECTS ON THE PATIENT OR DELAYS IN THE SURGICAL TIMELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25190953 ↗
• MalfunctionJun 23, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE VA LOCKING PATELLA PLATE 2.7 ANTERIOR 6-HOLE, STAINLESS STEEL, 2.0 MM THREADED GUIDE FOR 2.7MM SCREW, 2.7 MM VA LCP CLAVICLE PLATES, 2.0 MM DRILL BIT/QUICK COUPLING 140 MM, 60 MM CALIBRATION AND THE TWO (2) 2.7 MM/3.5MM VA-LCP MEDIAL DISTAL HUMERUS PLATES HAD AN UNKNOWN ALLEGATION. THERE WAS NO KNOWN SURGICAL DELAY. PROCEDURE WAS COMPLETED WITHOUT ANY DELAY. THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT QC 140MM 60MM CALIBRATION. THIS IS REPORT 7 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12053401 ↗
• MalfunctionJun 23, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE VA LOCKING PATELLA PLATE 2.7 ANTERIOR 6-HOLE, STAINLESS STEEL, 2.0 MM THREADED GUIDE FOR 2.7MM SCREW, 2.7 MM VA LCP CLAVICLE PLATES, 2.0 MM DRILL BIT/QUICK COUPLING 140 MM, 60 MM CALIBRATION AND THE TWO (2) 2.7 MM/3.5MM VA-LCP MEDIAL DISTAL HUMERUS PLATES HAD AN UNKNOWN ALLEGATION. THERE WAS NO KNOWN SURGICAL DELAY. PROCEDURE WAS COMPLETED WITHOUT ANY DELAY. THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT QC 140MM 60MM CALIBRATION. THIS IS REPORT 8 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12053400 ↗
• MalfunctionJun 23, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE VA LOCKING PATELLA PLATE 2.7 ANTERIOR 6-HOLE, STAINLESS STEEL, 2.0 MM THREADED GUIDE FOR 2.7MM SCREW, 2.7 MM VA LCP CLAVICLE PLATES, 2.0 MM DRILL BIT/QUICK COUPLING 140 MM, 60 MM CALIBRATION AND THE TWO (2) 2.7 MM/3.5MM VA-LCP MEDIAL DISTAL HUMERUS PLATES HAD AN UNKNOWN ALLEGATION. THERE WAS NO KNOWN SURGICAL DELAY. PROCEDURE WAS COMPLETED WITHOUT ANY DELAY. THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT QC 140MM 60MM CALIBRATION. THIS IS REPORT 9 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12053394 ↗
• MalfunctionJun 23, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE VA LOCKING PATELLA PLATE 2.7 ANTERIOR 6-HOLE, STAINLESS STEEL, 2.0 MM THREADED GUIDE FOR 2.7MM SCREW, 2.7 MM VA LCP CLAVICLE PLATES, 2.0 MM DRILL BIT/QUICK COUPLING 140 MM, 60 MM CALIBRATION AND THE TWO (2) 2.7 MM/3.5MM VA-LCP MEDIAL DISTAL HUMERUS PLATES HAD AN UNKNOWN ALLEGATION. THERE WAS NO KNOWN SURGICAL DELAY. PROCEDURE WAS COMPLETED WITHOUT ANY DELAY. THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT QC 140MM 60MM CALIBRATION. THIS IS REPORT 10 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12053386 ↗
• MalfunctionJun 23, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE VA LOCKING PATELLA PLATE 2.7 ANTERIOR 6-HOLE, STAINLESS STEEL, 2.0 MM THREADED GUIDE FOR 2.7MM SCREW, 2.7 MM VA LCP CLAVICLE PLATES, 2.0 MM DRILL BIT/QUICK COUPLING 140 MM, 60 MM CALIBRATION AND THE TWO (2) 2.7 MM/3.5MM VA-LCP MEDIAL DISTAL HUMERUS PLATES HAD AN UNKNOWN ALLEGATION. THERE WAS NO KNOWN SURGICAL DELAY. PROCEDURE WAS COMPLETED WITHOUT ANY DELAY. THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT QC 140MM 60MM CALIBRATION. THIS IS REPORT 11 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12053383 ↗
• MalfunctionJun 23, 2021Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE VA LOCKING PATELLA PLATE 2.7 ANTERIOR 6-HOLE, STAINLESS STEEL, 2.0 MM THREADED GUIDE FOR 2.7MM SCREW, 2.7 MM VA LCP CLAVICLE PLATES, 2.0 MM DRILL BIT/QUICK COUPLING 140 MM, 60 MM CALIBRATION AND THE TWO (2) 2.7 MM/3.5MM VA-LCP MEDIAL DISTAL HUMERUS PLATES HAD AN UNKNOWN ALLEGATION. THERE WAS NO KNOWN SURGICAL DELAY. PROCEDURE WAS COMPLETED WITHOUT ANY DELAY. THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT QC 140MM 60MM CALIBRATION. THIS IS REPORT 12 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12053377 ↗
• MalfunctionJun 23, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE VA LOCKING PATELLA PLATE 2.7 ANTERIOR 6-HOLE, STAINLESS STEEL, 2.0 MM THREADED GUIDE FOR 2.7MM SCREW, 2.7 MM VA LCP CLAVICLE PLATES, 2.0 MM DRILL BIT/QUICK COUPLING 140 MM, 60 MM CALIBRATION AND THE TWO (2) 2.7 MM/3.5MM VA-LCP MEDIAL DISTAL HUMERUS PLATES HAD AN UNKNOWN ALLEGATION. THERE WAS NO KNOWN SURGICAL DELAY. PROCEDURE WAS COMPLETED WITHOUT ANY DELAY. THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT QC 140MM 60MM CALIBRATION. THIS IS REPORT 4 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12051764 ↗
• MalfunctionJun 23, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE VA LOCKING PATELLA PLATE 2.7 ANTERIOR 6-HOLE, STAINLESS STEEL, 2.0 MM THREADED GUIDE FOR 2.7MM SCREW, 2.7 MM VA LCP CLAVICLE PLATES, 2.0 MM DRILL BIT/QUICK COUPLING 140 MM, 60 MM CALIBRATION AND THE TWO (2) 2.7 MM/3.5MM VA-LCP MEDIAL DISTAL HUMERUS PLATES HAD AN UNKNOWN ALLEGATION. THERE WAS NO KNOWN SURGICAL DELAY. PROCEDURE WAS COMPLETED WITHOUT ANY DELAY. THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT QC 140MM 60MM CALIBRATION. THIS IS REPORT 6 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12051762 ↗
• MalfunctionJun 23, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE VA LOCKING PATELLA PLATE 2.7 ANTERIOR 6-HOLE, STAINLESS STEEL, 2.0 MM THREADED GUIDE FOR 2.7MM SCREW, 2.7 MM VA LCP CLAVICLE PLATES, 2.0 MM DRILL BIT/QUICK COUPLING 140 MM, 60 MM CALIBRATION AND THE TWO (2) 2.7 MM/3.5MM VA-LCP MEDIAL DISTAL HUMERUS PLATES HAD AN UNKNOWN ALLEGATION. THERE WAS NO KNOWN SURGICAL DELAY. PROCEDURE WAS COMPLETED WITHOUT ANY DELAY. THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT QC 140MM 60MM CALIBRATION. THIS IS REPORT 5 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12051755 ↗
• MalfunctionJun 23, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE VA LOCKING PATELLA PLATE 2.7 ANTERIOR 6-HOLE, STAINLESS STEEL, 2.0 MM THREADED GUIDE FOR 2.7MM SCREW, 2.7 MM VA LCP CLAVICLE PLATES, 2.0 MM DRILL BIT/QUICK COUPLING 140 MM, 60 MM CALIBRATION AND THE TWO (2) 2.7 MM/3.5MM VA-LCP MEDIAL DISTAL HUMERUS PLATES HAD AN UNKNOWN ALLEGATION. THERE WAS NO KNOWN SURGICAL DELAY. PROCEDURE WAS COMPLETED WITHOUT ANY DELAY. THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT QC 140MM 60MM CALIBRATION. THIS IS REPORT 2 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12051739 ↗
• MalfunctionJun 23, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE VA LOCKING PATELLA PLATE 2.7 ANTERIOR 6-HOLE, STAINLESS STEEL, 2.0 MM THREADED GUIDE FOR 2.7MM SCREW, 2.7 MM VA LCP CLAVICLE PLATES, 2.0 MM DRILL BIT/QUICK COUPLING 140 MM, 60 MM CALIBRATION AND THE TWO (2) 2.7 MM/3.5MM VA-LCP MEDIAL DISTAL HUMERUS PLATES HAD AN UNKNOWN ALLEGATION. THERE WAS NO KNOWN SURGICAL DELAY. PROCEDURE WAS COMPLETED WITHOUT ANY DELAY. THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT QC 140MM 60MM CALIBRATION. THIS IS REPORT 3 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12051728 ↗
• MalfunctionJun 23, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE VA LOCKING PATELLA PLATE 2.7 ANTERIOR 6-HOLE, STAINLESS STEEL, 2.0 MM THREADED GUIDE FOR 2.7MM SCREW, 2.7 MM VA LCP CLAVICLE PLATES, 2.0 MM DRILL BIT/QUICK COUPLING 140 MM, 60 MM CALIBRATION AND THE TWO (2) 2.7 MM/3.5MM VA-LCP MEDIAL DISTAL HUMERUS PLATES HAD AN UNKNOWN ALLEGATION. THERE WAS NO KNOWN SURGICAL DELAY. PROCEDURE WAS COMPLETED WITHOUT ANY DELAY. THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT QC 140MM 60MM CALIBRATION. THIS IS REPORT 1 OF 12 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12050302 ↗
• MalfunctionApr 1, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, A SURGICAL PROCEDURE WAS PERFORMED. FOUR (4) DRILL BIT HIT WIRES AND SNAPPED, CLAMP WAS USED, AND THE TIP BROKE OFF. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS A SURGICAL DELAY OF 3 MINUTES. IT WAS UNKNOWN IF FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN K-WIRES (PART# UNKNOWN; LOT# UNKNOWN: QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) 2.0 DRILL BIT QC 140 60 CALIBRATION. THIS REPORT IS 6 OF 7 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11602760 ↗
• MalfunctionApr 1, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, A SURGICAL PROCEDURE WAS PERFORMED. FOUR (4) DRILL BIT HIT WIRES AND SNAPPED, CLAMP WAS USED, AND THE TIP BROKE OFF. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS A SURGICAL DELAY OF 3 MINUTES. IT WAS UNKNOWN IF FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN K-WIRES (PART# UNKNOWN; LOT# UNKNOWN: QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) 2.0 DRILL BIT QC 140 60 CALIBRATION. THIS REPORT IS 2 OF 7 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11602752 ↗