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Incident · Malfunction

Stryker Mako acetabular inserter: screw found missing after use (FDA MAUDE)

An FDA MAUDE malfunction report describes a screw found missing from a Stryker Mako acetabular inserter after use, with a second similar event previously reported. Source: FDA MAUDE MDR key 20350575, openFDA device event / accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.

Occurred 2024-08-15 · Stryker · Investigated by FDA

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Track Stryker Mako acetabular inserter: screw found missing after use (FDA MAUDE)

Machine-readable surfaces

Sources (2)

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
  2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=20181233&pc=OLO

Common questions

What happened in Stryker Mako acetabular inserter: screw found missing after use (FDA MAUDE)?
An FDA MAUDE malfunction report describes a screw found missing from a Stryker Mako acetabular inserter after use, with a second similar event previously reported. Source: FDA MAUDE MDR key 20350575, openFDA device event / accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.
When did this incident occur?
The incident is recorded as occurring on August 15, 2024 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
Who was involved in Stryker Mako acetabular inserter: screw found missing after use (FDA MAUDE)?
The incident is recorded as involving Stryker on the DEPLOY registry. No specific robot model is linked to this incident in the registry.
Has anyone responded to Stryker Mako acetabular inserter: screw found missing after use (FDA MAUDE)?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of Stryker Mako acetabular inserter: screw found missing after use (FDA MAUDE)?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 2 sources (2 primary) · last reviewed 2026-08-09

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-08-09

Sources by quality tier

2
primary-fda-database
FDA database

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for Stryker Mako acetabular inserter: screw found missing after use (FDA MAUDE).

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Canonical ID 47430238-4e81-4db8-a76f-62c6bf448db8