_Incident · Malfunction_

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

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

- **Occurred:** 2025-04-01
- **Kind:** `malfunction`
- **Status (derived):** active
- **Company:** [Stryker](/companies/stryker.md) (id: `661fbd42-9fcb-4d47-8a74-7a23d161d57b`)

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.

## Sources (0)

_No sources on file._

## 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.


_API: GET /v1/incidents/a84948e8-9d27-4704-b879-374285fb0394 · sources: /v1/incidents/a84948e8-9d27-4704-b879-374285fb0394/sources · responses: /v1/incidents/a84948e8-9d27-4704-b879-374285fb0394/responses · status: /v1/incidents/a84948e8-9d27-4704-b879-374285fb0394/status · canonical URL: /incidents/stryker-mako-reamer-missing-screw-maude-2025_