N/A 01.06808.300Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024288669), received between Dec 7, 2018 and Jun 9, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A KIT INSPECTION, IT WAS NOTED THAT THE THREAD OF THE ROD IS BROKEN OFF IN THE SHAFT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167460 ↗
• MalfunctionMar 26, 2025Damaged Thread; Damaged Thread

  IT WAS REPORTED THAT AVENIR SLAP HAMMER BROKE DURING USE, NO PARTS FELL INTO PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21698680 ↗
• MalfunctionAug 26, 2021Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12370327 ↗
• MalfunctionAug 26, 2021Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12370325 ↗
• MalfunctionNov 17, 2020Device Damaged by Another Device; Device Damaged by Another Device

  NO CHANGE TO PREVIOUSLY REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10850522 ↗
• InjurySep 25, 2020Mechanical Jam; Appropriate Device Problem Term/Code Not Available; Mechanical Jam; Appropriate Device Problem Term/Code Not Available

  THE SURGEON WAS NOT ABLE TO REMOVE THE AVENIR STEM WITH THE EXTRACTORS AS THE THREADS WOULDN'T SCREW IN. THERE WAS A SURGICAL DELAY OF 1 HR. APPROXIMATELY, EACH OF THE INSTRUMENTS WERE USED AROUND 10 TIMES. BOTH OF THESE INSTRUMENTS WERE NOT VERY OLD AND WERE REPLACED IN THE LAST YEAR.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10585860 ↗
• MalfunctionDec 7, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE SURGEON TRIED TO EXTRACT A STEM AND DOING SO DAMAGED THE THREAD OF TWO INSTRUMENTS AT THE DISTAL PART. ALL PIECES WERE RETRIEVED. NO DELAY OF SURGERY AND NO HARM TO PATIENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8141071 ↗
• MalfunctionDec 7, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE SURGEON TRIED TO EXTRACT A STEM AND DOING SO DAMAGED THE THREAD OF TWO INSTRUMENTS AT THE DISTAL PART. ALL PIECES WERE RETRIEVED. NO DELAY OF SURGERY AND NO HARM TO PATIENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8141068 ↗