NA 03.226.016Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982077097), received between Jan 18, 2019 and Sep 25, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16, 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.

• MalfunctionSep 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON SEPTEMBER 18, 2024, THE INSTRUMENT DOES NOT GRAB THE SCREW WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20301489 ↗
• MalfunctionFeb 21, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE SURGERY, THE SLEEVE AND HANDLE COULD NOT BE ENGAGED WELL. THE SURGEON DIDN¿T USE THE HANDLE AND DID INSERTION ONLY USING THE SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) COMPRESSION SLEEVE FOR 2.4MM HEADLESS COMPRESSION SCREW THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18754278 ↗
• MalfunctionMar 2, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) FOR A DISTAL RADIUS FRACTURE. IMPLANT INSERTION WAS COMPLETED WITHOUT ANY PROBLEM, AND THEN A METAL FRAGMENT WAS FOUND NEAR THE SCREW INSERTION SITE DURING CLEANING BEFORE WOUND CLOSURE. THE FRAGMENT WAS REMOVED. IT MAY BE A FRAGMENT OF THE DRILL BIT, SLEEVE, OR SCREWDRIVER SHAFT. X-RAY WAS PERFORMED AND CONFIRMED THAT NO OTHER FRAGMENTS WERE PRESENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR A COMPRESSION SLEEVE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11399170 ↗
• MalfunctionJan 18, 2019Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, A HEADLESS COMPRESSION SCREW, SHORT THREAD WAS NOT TWISTING WELL IN THE COMPRESSION SLEEVE DURING AN UNKNOWN SURGERY. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS ONE (1) COMPRESSION SLEEVE FOR 2.4MM HEADLESS COMPRESSION SCREW. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8262891 ↗