NA 206.040Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982147349), received between Nov 5, 2018 and Nov 16, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE DRILL BITS AND SCREWS BROKE WHILE DRILLING AROUND A FEMORAL PROSTHESIS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. FRAGMENTS WERE GENERATED; IT IS UNKNOWN WHETHER THEY WERE EASILY REMOVED WITHOUT FURTHER INTERVENTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 4.0MM CANCELLOUS BONE SCREW FULLY THREADED/40MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15805004 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A REMOVAL SURGERY OF PROXIMAL TIBIA HARDWARE DUE TO PAIN. THE PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS NO KNOWN PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR ONE (1) 4.0 CANCELLOUS BONE SCREW FULLY THRD/40. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12778763 ↗
• MalfunctionOct 14, 2019Break; Break

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE PROXIMAL HUMERUS ON (B)(6) 2019, THE 4.0 CANCELLOUS SCREW SNAPPED HALFWAY INTO THE INTRAMEDULLARY. THE PROCEDURE WAS COMPLETED BY RETRIEVING THE BROKEN PORTION WITH NARROW RONGEURS, INSIDE THE CANAL, AND THEN PROCEEDING AS PLANNED, WITH PLATES AND SCREWS. THE SURGEON THEN ELECTED TO USE A CORTICAL SCREW, IN PLACE OF THE CANCELLOUS. THE SCREW WAS BEING RUN THREW A PLATE. THE ISSUE HAPPENED WHILE THE SURGEON WAS IMPLANTING THE REPORTED SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 5 MINUTES SURGICAL DELAY. THE SCREW FRAGMENT WAS EASILY RETRIEVED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS IS REPORT 1 FOR 1 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9186352 ↗
• InjuryNov 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH A LOCKING COMPRESSION PLATE (LCP) 8 HOLE PLATE, FIVE (5) CORTEX SCREWS, TWO (2) CANNULATED SCREWS, AND ONE (1) CANCELLOUS BONE SCREW ON (B)(6) 2017 FOR REPAIR OF A BROKEN RIGHT TIBIA AND FIBULA. SURGERY WAS COMPLETED SUCCESSFULLY. IN (B)(6) 2017, PATIENT REPORTS SKIN ISSUES. IN (B)(6) 2018, PATIENT REPORTS BOTH LEGS FROM KNEE TO FOOT, FOOT AND HANDS, HAD A RASH AND SKIN IRRITATION. PATIENT WAS REFERRED TO A DERMATOLOGIST IN (B)(6) 2018. DERMATOLOGIST DETERMINED PATIENT IS ALLERGIC TO THE IMPLANTED DEVICES. THIS REPORT IS FOR ONE (1) 4.0MM CANCELLOUS BONE SCREW. THIS IS REPORT 7 OF 9 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Rash; Skin Irritation

  MAUDE report 8038372 ↗