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Incident · Malfunction

Stryker Mako Reamer: screw missing from the reamer handle, located outside the operative site on X-ray (FDA MAUDE)

An FDA MAUDE malfunction report describes a screw missing from a Stryker Mako reamer handle, with X-ray confirming the screws were located outside the operative site; the event occurred twice. Source: FDA MAUDE MDR key 21918326, openFDA device event / accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.

Occurred 2025-04-01 · Stryker

Track Stryker Mako Reamer: screw missing from the reamer handle, located outside the operative site on X-ray (FDA MAUDE)

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Common questions

What happened in Stryker Mako Reamer: screw missing from the reamer handle, located outside the operative site on X-ray (FDA MAUDE)?
An FDA MAUDE malfunction report describes a screw missing from a Stryker Mako reamer handle, with X-ray confirming the screws were located outside the operative site; the event occurred twice. Source: FDA MAUDE MDR key 21918326, openFDA device event / accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.
When did this incident occur?
The incident is recorded as occurring on April 1, 2025 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 Reamer: screw missing from the reamer handle, located outside the operative site on X-ray (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 Reamer: screw missing from the reamer handle, located outside the operative site on X-ray (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 Reamer: screw missing from the reamer handle, located outside the operative site on X-ray (FDA MAUDE)?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Unreviewed · no sources on file · last reviewed 2026-06-27

Verification posture

Unreviewed

Low confidence

Review state

Stable

Last reviewed 2026-06-27

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

Methodology surface for Stryker Mako Reamer: screw missing from the reamer handle, located outside the operative site on X-ray (FDA MAUDE).

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Canonical ID a84948e8-9d27-4704-b879-374285fb0394