Tornier Perform MWM051Recalls & reported problems
Tornier, Inc. · Humeral Impactor Tip · Class 1
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00846832082841), received between Mar 17, 2025 and Jan 30, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Fracture” (8 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.
Reports received per month
Most reported problems
Device problems
- Fracture8
- Break4
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Insufficient Information1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 30, 2026Fracture
IT WAS REPORTED THAT THE IMPACTOR TIP BROKE DURING SURGERY. NO DEBRIS REPORTED. THE PROCEDURE WAS SUCCESSFULLY CONCLUDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24223708 ↗MalfunctionJan 16, 2026Fracture
IT WAS REPORTED THAT THE IMPACTOR TIP BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24096788 ↗MalfunctionNov 6, 2025Fracture; Fracture
IT WAS REPORTED THAT THE HUMERAL SIZE 1/2 IMPACTOR TIP BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23491005 ↗MalfunctionAug 29, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE HUMERAL SIZE 1-2 IMPACTOR TIP BROKE.
Patient problems: Insufficient Information
MAUDE report 22922069 ↗MalfunctionAug 28, 2025Crack; Fracture; Crack; Fracture
IT WAS REPORTED THAT THE IMPACTOR TIP WAS FOUND BROKEN IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22912575 ↗MalfunctionApr 22, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE IMPACTOR TIPS BROKE UPON IMPACTION WHILE TRAILING THE STEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21886035 ↗MalfunctionMar 20, 2025Break; Fracture; Break; Fracture
DURING A PRIMARY SURGERY, IT WAS REPORTED THAT THE IMPACTOR TIP BROKE UPON IMPACTION. NO DEBRIS OR HARD BONE WAS NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21653722 ↗MalfunctionMar 17, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT DURING SURGERY BOTH IMPACTOR TIPS BROKE DURING IMPACTION. ALL DEBRIS WAS REMOVED FROM THE SURGICAL FIELD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21626167 ↗
Other IMPACTOR devices
- PINNACLE 2217-50-041Depuy (Ireland) · IMPACTOR4,295 reports
- ATTUNE 2544-01-006Depuy (Ireland) · IMPACTOR1 recall2,539 reports
- ATTUNE 2544-01-003Depuy (Ireland) · IMPACTOR1 recall1,498 reports
- ATTUNE 2544-01-017Depuy (Ireland) · IMPACTOR1 recall1,456 reports
- ATTUNE 2544-01-004Depuy (Ireland) · IMPACTOR1 recall875 reports
- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.