NA 338.25Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982193285), received between Aug 19, 2022 and Mar 10, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 10, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE IMPACTOR TIP WAS UNABLE TO STERILIZE/ASSEMBLE. THERE WAS CHIPPING AND CRACKING. IT WAS UNABLE TO USE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) SMALL IMPACTOR TIP THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16522996 ↗
• MalfunctionAug 19, 2022Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, THE FOLLOWING PRODUCT ISSUES WERE DISCOVERED. BOTH THE STANDARD LENGTH AND SHORT DHS REAMING HEADS WERE FOUND TO BE DULL. THE 8MM DRILL BIT FOR THE REAMER WAS ALSO FOUND TO BE DULL. THE DHS IMPACTOR WAS FOUND TO HAVE FRACTURED AT THE TIP. THIS REPORT IS FOR A SMALL IMPACTOR TIP. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15260967 ↗