NA 398.54Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982201430), received between Dec 30, 2016 and Jan 15, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT THE PRODUCTS ARE NOT WORKING PROPERLY/HAVE BROKEN. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24085472 ↗
• MalfunctionMar 22, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HANDLE OF THE BONE SPIKE PUSHER WAS SPLIT DURING SURGERY. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE STRAIGHT BALL SPIKE 337MM. THIS IS REPORT 1 OF 1 FOR (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18959295 ↗
• MalfunctionDec 4, 2020Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE REPORTER WAS GIVEN A STRAIGHT BALL SPIKE WITH A FLATTENED POINT DURING AN INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR 1 STRAIGHT BALL SPIKE 337MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10945580 ↗
• MalfunctionJun 18, 2018Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THERE WERE THREE (3) DEVICES DISCOVERED TO HAVE MALFUNCTIONED; IT WAS IDENTIFIED AT THE STERILE PROCESSING DEPARTMENT (SPD). THE STRAIGHT BALL SPIKE WAS LEAKING A BROWN RESIDUE. THE SHARP HOOK WAS BENT IN AN INCORRECT DIRECTION, AND THE PERIOSTEAL ELEVATOR HANDLE HAS CRACKED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR A STRAIGHT BALL SPIKE 337MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7609217 ↗
• MalfunctionDec 30, 2016Break; Break

  IT WAS REPORTED THAT THE HAMMER 500 GRAMS, STRAIGHT BALL SPIKE 337 MM AND HAMMER 700 GRAMS WERE NOTICED TO BE BROKEN DURING THE DECONTAMINATION PROCESS. THERE WAS NO PATIENT OR CASE INVOLVEMENT. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6216038 ↗