CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 34mm 8124-034Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00848665033601), received between Apr 4, 2024 and Sep 9, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2025Break; Positioning Failure; Break; Positioning Failure

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 8124-034 CN LOCK SCREW WOULD NOT LOCK INTO THE PLATE. THIS WAS DISCOVERED A PROXIMAL HUMERUS PROCEDURE WHICH WAS COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23004466 ↗
• MalfunctionJun 12, 2024Positioning Failure; Positioning Failure

  ON 1/31/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A 8124-034 LOCKING SCREWS WOULD NOT LOCK INTO THE PLATE. THIS OCCURRED DURING A PROCEDURE ON (B)(6) 2022. THE CASE WAS COMPLETED BY USING A NEW 8124-034 WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19519562 ↗
• MalfunctionApr 4, 2024Positioning Failure; Positioning Failure

  ON 3/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 8124-034 CN LOCK SCREW, F THREAD 4.0MM X 34MM, CN LOCK SCREW, F THREAD 4.0MM X 36MM, AN 8124-036 CN LOCK SCREW, F THREAD, AND QTY. 2 OF AN 8124-038 CN LOCK SCREW, F THREAD 4.0MM X 38MM FROM LOANER SET RAR-9912S WAS NOT FUNCTIONING AND DID NOT LOCK INTO THE PLATE. THIS WAS DISCOVERED DURING A PROXIMAL HUMERUS ORIF PROCEDURE. THE CASE WAS DELAYED BY APPROXIMATELY 60 MINUTES. THE SCREWS WERE INSERTED ON POWER INITIALLY AND TIGHTENED BY HAND. THE PILOT HOLES WERE DRILLED WITH POWER. THE CASE WAS COMPLETED WITH 4.0 PARTIALLY THREADED SCREWS. THE PATIENT HAS NOT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19043610 ↗