NA SD310.018Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982003843), received between Apr 9, 2024 and May 15, 2024 — classified as 4 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 15, 2024Corroded; Material Twisted/Bent; Corroded; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE RUST WAS INSPECTED ON DEVICES POST OPERATIVELY DUE TO WEAR. THERE WERE NO PATIENT STATUS/ OUTCOME / CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) 6.5 STRAIGHT BALL W/O SPIKE 416 LENGTH . THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19325754 ↗
• MalfunctionMay 15, 2024Corroded; Material Twisted/Bent; Corroded; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE RUST WAS INSPECTED ON DEVICES POST OPERATIVELY DUE TO WEAR. THERE WERE NO PATIENT STATUS/ OUTCOME / CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) 6.5 STRAIGHT BALL W/O SPIKE 416 LENGTH THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19325747 ↗
• MalfunctionApr 9, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE WHILE MALLETING THE BALL INSTRUMENT, A PIECE CHIPPED OFF WHILE MALLETING INTO TO CONTOUR A LOW PROFILE PLATE. OPENED A SECOND ONE AND IT ENDED UP CHIPPING AS WELL. THERE WAS NO SURGICAL DELAY AND NO PATIENT OUTCOME REPORTED. THIS REPORT IS FOR ONE (1) 6.5 STRAIGHT BALL W/O SPIKE 416 LENGTH THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19074022 ↗
• MalfunctionApr 9, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE WHILE MALLETING THE BALL INSTRUMENT, A PIECE CHIPPED OFF WHILE MALLETING INTO TO CONTOUR A LOW PROFILE PLATE. OPENED A SECOND ONE AND IT ENDED UP CHIPPING AS WELL. THERE WAS NO SURGICAL DELAY AND NO PATIENT OUTCOME REPORTED. THIS REPORT IS FOR ONE (1) 6.5 STRAIGHT BALL W/O SPIKE 416 LENGTH THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19074015 ↗