Tornier Humeral Nail 0020500Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00846832091065), received between Jun 17, 2022 and Dec 23, 2023 — classified as 4 injuries.

2 other recalls cover devices cleared under the same FDA submission (K082754, K230352); they may or may not involve this specific model.

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 18, 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.

• InjuryDec 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A POST-OP COMPLICATIONS OF GLENOHUMERAL ARTHRITIS. X-RAYS SHOW COMPLETE JOINT SPACE COLLAPSE AND PATIENT IS IN SIGNIFICANT PAIN. PATIENT WAS GIVEN AN INJECTION OF 40MG KENALOG,2ML LIDOCAINE,7ML ROPIVACAINE INTO GLENOHUMERAL JOINT SPACE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 18389727 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A STUDY THAT THE PATIENT HAD AN INCREASE IN PAIN WITHOUT INJURY. THE PATIENT WAS GIVEN 2ML KENALOG, 2ML LIDOCAINE, 7ML ROPIVACAINE; INJECTION INTO THE SHOULDER ARTICULATION AND SUBACROMIAL SPACE. A WEEK LATER THE PATIENT WAS GIVEN1ML KENALOG, 2ML LIDOCAINE, 7ML ROPIVICAINE, INJECTED INTO THE GLENOHUMERAL ARTICULATION

  Patient problems: Implant Pain

  MAUDE report 18383180 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A STUDY THAT THE PATIENT SUFFERED AVASCULAR NECROSIS OF HUMERAL HEAD WITH COLLAPSE. PATIENT WILL COME BACK IN 6 MONTHS AND DECIDE IF SHE WANTS FURTHER SURGERY". IT IS UNKNOWN IF THE SURGERY OCCURRED OR NOT.

  Patient problems: Necrosis

  MAUDE report 18379500 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING OF PAIN AND TEARING NOISES IN ARM. X-RAYS SHOWED AVN (AVASCULAR NECROSIS) WITH MEDIAL HUMERAL HEAD COLLAPSE. THE PATIENT WILL GET A METAL SUPPRESSION MRI AND LAB WORK TO DETERMINE IF THERE IS A LOW GRADE INFECTION. THE EVENT IS ONGOING.

  Patient problems: Implant Pain; Limb Fracture; Necrosis

  MAUDE report 14738636 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082754, K230352. One submission often covers many models, so check the product and lot details in each record.

• Z-1757-2018 · Mar 26, 2018 · Terminated
  AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or di
• Z-2315-2015 · Jun 25, 2015 · Terminated
  Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.