Endo-Model Knee System - Instruments 64-1181/16Recalls & reported problems
WALDEMAR LINK GmbH & Co. KG · Surgical screwdriver, reusable - General instrument · Class 1
All models of Endo-Model Knee System - Instruments (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04026575397044), received between Jan 19, 2024 and Mar 25, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture3
- Off-Label Use3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2024Fracture; Off-Label Use; Fracture; Off-Label Use
IT WAS NOTICED DURING A SURGERY THAT THE TIP OF THE 2.0MM HEX SCREWDRIVER WAS BROKEN OFF PRIOR TO USE. [CUSTOMER]
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18966861 ↗MalfunctionJan 19, 2024Fracture; Off-Label Use; Fracture; Off-Label Use
THE TIP OF THE 2.0 MM HEX SCREWDRIVER BROKE OFF WHEN SCREWING IN THE CONNECTING COMPONENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18542258 ↗MalfunctionJan 19, 2024Fracture; Off-Label Use; Fracture; Off-Label Use
THE TIP OF THE 2.0 MM HEX SCREWDRIVER BROKE OFF WHEN SCREWING IN THE CONNECTING COMPONENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18542256 ↗
Other SCREWDRIVER devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page