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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 · Investigated by FDA

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Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
Track Stryker Mako Reamer: screw missing from the reamer handle, located outside the operative site on X-ray (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=21918326&pc=OLO

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: 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 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