CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 24mm 8124-024Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848665033557), received between Feb 2, 2024 and Jun 12, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2024Positioning Failure; Positioning Failure

  ON 1/27/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN 8124-024 CN LOCK SCREW HAD AN ISSUE. DURING A PROXIMAL HUMERUS FRACTURE PROCEDURE ON (B)(6) 2023, WHEN THE SURGEON WAS TRYING TO SCREW IT INTO THE PLATE INSIDE THE PATIENT, IT WOULD NOT LOCK. THE SCREW WAS REMOVED IN ONE PIECE, NOTHING BROKE INSIDE THE PATIENT. ANOTHER SCREW WITH THE SAME PART AND LOT NUMBER WAS USED. THIS ONE DID LOCK AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO IMPACT TO THE PATIENT. THE DEVICE WAS DISCARDED, NO PICTURES WERE TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19522186 ↗
• InjuryFeb 2, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 01/19/2024, IT WAS REPORTED BY A PATIENT WHO UNDERWENT A PROCEDURE WHERE ARTHREX DEVICES WERE IMPLANTED WAS EXPERIENCING A PAINFUL REACTION. THE INITIAL PROCEDURE OCCURRED ON (B)(6) 2023. THE PATIENT BEGAN TO EXPERIENCE PAIN 3-4 WEEKS POST. THE PATIENT WAS REFERRED TO A PAIN SPECIALIST WHO SUGGESTED SHE WAS HAVING AN ALLERGIC REACTION AS THE SCAR WAS RED AND PUFFY. SHE NOTED SHE FEELS TERRIBLE PAIN AND THROBBING, AND WHEN ATTEMPTING TO LIFT, IT'S PAINFUL. THE SURGEON MENTIONED SHE COULD HAVE THE DEVICES REMOVED IN 6 MONTHS FROM HER SURGERY DATE. HOWEVER, SHE IS NOT SURE SHE CAN TAKE THE PAIN THAT MUCH LONGER. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Hypersensitivity/Allergic reaction; Implant Pain

  MAUDE report 18633984 ↗