Affiniti 9000381Recalls & reported problems
Tornier, Inc. · Plastic Darrach · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00846832021963), received between Apr 15, 2025 and Dec 16, 2025 — classified as 4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Deformation2
- Material Fragmentation2
- Break1
- Device Damaged by Another Device1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2025Device Damaged by Another Device; Device Damaged by Another Device
INSTRUMENT WAS HIT WITH A SAW BLADE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23817788 ↗MalfunctionJun 5, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE PLASTIC DARRACH RETRACTOR BROKE DURING SHOULDER REPLACEMENT OPERATION. SURGEON WAS ATTEMPTING TO DISLOCATE SHOULDER, AND THE RETRACTOR BROKE IN TWO PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22153118 ↗MalfunctionApr 15, 2025Material Fragmentation; Material Deformation; Material Fragmentation; Material Deformation
IT WAS REPORTED THAT ITEMS FROM A PRIMARY SURGERY SHOWED HAD CHUNKS MISSING DUE TO PROLONGED USE. THESE PRODUCTS, WHICH HAVE BEEN IN USE FOR 5-7 YEARS, WILL BE RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21838675 ↗MalfunctionApr 15, 2025Material Fragmentation; Material Deformation; Material Fragmentation; Material Deformation
IT WAS REPORTED THAT ITEMS FROM A PRIMARY SURGERY SHOWED HAD CHUNKS MISSING DUE TO PROLONGED USE. THESE PRODUCTS, WHICH HAVE BEEN IN USE FOR 5-7 YEARS, WILL BE RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21838642 ↗
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- NA 2176-10-000Depuy (Ireland) · RETRACTOR51 reports
- Fathom MR2-102050Seaspine Orthopedics Corporation · RETRACTOR1 recall1 report
- Omni-Tract® 10269Integra Lifesciences Corporation · RETRACTOR1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.